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MEDPOR

Model 5444-0-310 · Stryker Leibinger GmbH & Co. KG · DI 07613252457640

FWP — Prosthesis, Chin, Internal · Class II · 21 CFR 878.3550

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 (6)

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.

Injury: 5 · Malfunction: 1

12342019-01: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 1.25/device2019-05: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-11: 1 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.33/device2020-10: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 4/device2021-06: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.75/device2021-12: 3 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1.43/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2.5/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2024-05: 1 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1.33/device2026-04: 0 reports for this device; peer average 1/device2026-06: 1 reports for this device; peer average 1/device01030506081102030407080910030506080910120205060708100609101105060910110104050608091012030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0301.25
2019-0503
2019-0601
2019-0801
2019-1111
2020-0201
2020-0303
2020-0401
2020-0701
2020-0801
2020-0901.33
2020-1001
2021-0301
2021-0504
2021-0602
2021-0801
2021-0902
2021-1001.75
2021-1232
2022-0202
2022-0502
2022-0601.43
2022-0701
2022-0801
2022-1002
2023-0601
2023-0902.5
2023-1001
2023-1101
2024-0511
2024-0601
2024-0901
2024-1001
2024-1102
2025-0101
2025-0401
2025-0501
2025-0601
2025-0801
2025-0902
2025-1001
2025-1201
2026-0301.33
2026-0401
2026-0611
This device (reports/month)Average device in FWP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K143173 — cites (transitively): K121315 (d1), K103010 (d2), K043250 (d3) — cited as predicate by K152463, K153508

K254233 — cites (transitively): K191916 (d1), K203055 (d1), K152076 (d2), K153508 (d2), K190229 (d2), K121153 (d3), K143173 (d3), K153248 (d3), K053199 (d4), K121315 (d4), K103010 (d5), K043250 (d6)

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