07613327129267 · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

22 linked reportsMalfunction 19Injury 3

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1.5
2019-02	0	1
2019-03	0	2.71
2019-04	0	1.5
2019-05	0	2
2019-06	0	1.25
2019-07	0	1.67
2019-08	1	2
2019-09	0	1.5
2019-12	0	12
2020-01	0	2.14
2020-02	1	1.64
2020-03	0	2.75
2020-04	0	1.6
2020-05	0	2.57
2020-06	0	2.5
2020-07	0	3
2020-08	0	1.86
2020-09	0	4
2020-10	0	1.9
2020-11	0	2
2020-12	0	3
2021-01	0	1
2021-02	0	1
2021-03	1	1.75
2021-04	1	5
2021-05	0	1.33
2021-06	0	1.75
2021-07	0	1.2
2021-08	1	2.5
2021-09	0	1.67
2021-10	0	2.71
2021-11	0	1.5
2021-12	0	1.38
2022-01	0	2.25
2022-02	0	4.4
2022-03	0	3.5
2022-04	0	1
2022-05	0	1.4
2022-06	0	6.4
2022-07	0	2
2022-08	0	1.6
2022-09	1	1.25
2022-10	0	2
2022-11	0	3.25
2022-12	1	4.1
2023-01	2	1.67
2023-02	0	2
2023-03	0	4
2023-04	0	14.2
2023-05	0	1.67
2023-06	0	6.5
2023-07	0	2
2023-08	0	1.25
2023-09	1	1.75
2023-10	0	3.5
2023-11	0	1
2023-12	2	1.5
2024-01	0	5.5
2024-02	0	2.75
2024-03	0	1.75
2024-04	1	2.55
2024-05	0	2
2024-06	1	1.75
2024-07	0	1
2024-08	0	1.2
2024-09	0	6
2024-10	0	4.33
2024-11	0	3.5
2024-12	0	1.33
2025-01	0	1.83
2025-02	0	1
2025-03	0	1.33
2025-04	3	1.64
2025-05	1	2.5
2025-06	0	2
2025-07	1	3.5
2025-09	1	1
2025-10	0	1.17
2025-11	0	1
2025-12	1	2.8
2026-01	0	1.86
2026-02	0	1
2026-03	0	4.5
2026-04	0	10
2026-05	0	2.33
2026-06	1	3.4

This device (reports/month)Average device in GWO (reports/device/month)

Failure-mode summaryAI-generated

21 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-06-22	0008010177-2026-00082	Malfunction	—	exact di
2025-12-01	0008010177-2025-00161	Malfunction	Available	exact di
2025-09-11	0008010177-2025-00111	Malfunction	Available	exact di
2025-07-10	0008010177-2025-00089	Malfunction	Available	exact di
2025-05-20	0008010177-2025-00080	Malfunction	Available	exact di
2025-04-23	0008010177-2025-00057	Malfunction	Available	exact di
2025-04-23	0008010177-2025-00054	Malfunction	Available	exact di
2025-04-23	0008010177-2025-00053	Malfunction	Available	exact di
2024-06-19	0008010177-2024-00053	Malfunction	Available	exact di
2024-04-12	0008010177-2024-00029	Malfunction	Available	exact di
2023-12-19	0008010177-2023-00076	Malfunction	Available	exact di
2023-12-19	0008010177-2023-00075	Malfunction	Available	exact di
2023-09-05	0008010177-2023-00055	Injury	Available	exact di
2023-01-25	0008010177-2023-00008	Malfunction	Available	exact di
2023-01-18	0008010177-2023-00003	Injury	Available	exact di

Showing 1–15 of 22

Regulatory clearances

Predicate lineage

K152076
- K121153
  - K053199

Cited as predicate by: K191916

K190229
- K153248
  - K121153
    - K053199

Cited as predicate by: K201052, K203055

K203055
- K190229
  - K153248
    - K121153
      - K053199

Cited as predicate by: K203066, K254233

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility
2025-02-27	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG
2017-07-27	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG
2013-11-14	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG

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