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Unnamed device

Model 78-70030 · Stryker Leibinger GmbH & Co. KG · DI 07613327300055

GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320

UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (3)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 3

4711142019-01: 0 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2.71/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1.25/device2019-07: 0 reports for this device; peer average 1.67/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 12/device2020-01: 0 reports for this device; peer average 2.14/device2020-02: 0 reports for this device; peer average 1.64/device2020-03: 0 reports for this device; peer average 2.75/device2020-04: 0 reports for this device; peer average 1.6/device2020-05: 0 reports for this device; peer average 2.57/device2020-06: 0 reports for this device; peer average 2.5/device2020-07: 0 reports for this device; peer average 3/device2020-08: 0 reports for this device; peer average 1.86/device2020-09: 0 reports for this device; peer average 4/device2020-10: 0 reports for this device; peer average 1.9/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1.75/device2021-04: 0 reports for this device; peer average 5/device2021-05: 0 reports for this device; peer average 1.33/device2021-06: 0 reports for this device; peer average 1.75/device2021-07: 0 reports for this device; peer average 1.2/device2021-08: 0 reports for this device; peer average 2.5/device2021-09: 0 reports for this device; peer average 1.67/device2021-10: 0 reports for this device; peer average 2.71/device2021-11: 1 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 1.38/device2022-01: 0 reports for this device; peer average 2.25/device2022-02: 0 reports for this device; peer average 4.4/device2022-03: 0 reports for this device; peer average 3.5/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1.4/device2022-06: 0 reports for this device; peer average 6.4/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 1.6/device2022-09: 0 reports for this device; peer average 1.25/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 3.25/device2022-12: 0 reports for this device; peer average 4.1/device2023-01: 0 reports for this device; peer average 1.67/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 4/device2023-04: 0 reports for this device; peer average 14.2/device2023-05: 0 reports for this device; peer average 1.67/device2023-06: 0 reports for this device; peer average 6.5/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.25/device2023-09: 0 reports for this device; peer average 1.75/device2023-10: 0 reports for this device; peer average 3.5/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.5/device2024-01: 0 reports for this device; peer average 5.5/device2024-02: 0 reports for this device; peer average 2.75/device2024-03: 0 reports for this device; peer average 1.75/device2024-04: 0 reports for this device; peer average 2.55/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1.75/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1.2/device2024-09: 0 reports for this device; peer average 6/device2024-10: 0 reports for this device; peer average 4.33/device2024-11: 0 reports for this device; peer average 3.5/device2024-12: 0 reports for this device; peer average 1.33/device2025-01: 0 reports for this device; peer average 1.83/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1.33/device2025-04: 2 reports for this device; peer average 1.64/device2025-05: 0 reports for this device; peer average 2.5/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 3.5/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1.17/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 2.8/device2026-01: 0 reports for this device; peer average 1.86/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 4.5/device2026-04: 0 reports for this device; peer average 10/device2026-05: 0 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 3.4/device010203040506070809120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060709101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0201
2019-0302.71
2019-0401.5
2019-0502
2019-0601.25
2019-0701.67
2019-0802
2019-0901.5
2019-12012
2020-0102.14
2020-0201.64
2020-0302.75
2020-0401.6
2020-0502.57
2020-0602.5
2020-0703
2020-0801.86
2020-0904
2020-1001.9
2020-1102
2020-1203
2021-0101
2021-0201
2021-0301.75
2021-0405
2021-0501.33
2021-0601.75
2021-0701.2
2021-0802.5
2021-0901.67
2021-1002.71
2021-1111.5
2021-1201.38
2022-0102.25
2022-0204.4
2022-0303.5
2022-0401
2022-0501.4
2022-0606.4
2022-0702
2022-0801.6
2022-0901.25
2022-1002
2022-1103.25
2022-1204.1
2023-0101.67
2023-0202
2023-0304
2023-04014.2
2023-0501.67
2023-0606.5
2023-0702
2023-0801.25
2023-0901.75
2023-1003.5
2023-1101
2023-1201.5
2024-0105.5
2024-0202.75
2024-0301.75
2024-0402.55
2024-0502
2024-0601.75
2024-0701
2024-0801.2
2024-0906
2024-1004.33
2024-1103.5
2024-1201.33
2025-0101.83
2025-0201
2025-0301.33
2025-0421.64
2025-0502.5
2025-0602
2025-0703.5
2025-0901
2025-1001.17
2025-1101
2025-1202.8
2026-0101.86
2026-0201
2026-0304.5
2026-04010
2026-0502.33
2026-0603.4
This device (reports/month)Average device in GWO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K152076 — cites (transitively): K121153 (d1), K053199 (d2) — cited as predicate by K191916

K153248 — cites (transitively): K121153 (d1), K053199 (d2) — cited as predicate by K190229

K190229 — cites (transitively): K153248 (d1), K121153 (d2), K053199 (d3) — cited as predicate by K201052, K203055

K203055 — cites (transitively): K190229 (d1), K153248 (d2), K121153 (d3), K053199 (d4) — cited as predicate by K203066, K254233

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Stryker Leibinger GmbH & Co. KG

  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2017-07-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2013-11-14 Stryker Leibinger GmbH & Co. KG · 0 citations