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.
33 linked reportsMalfunction 33
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 12.92 |
| 2019-02 | 0 | 14.35 |
| 2019-03 | 1 | 14.05 |
| 2019-04 | 0 | 18.63 |
| 2019-05 | 2 | 19.54 |
| 2019-06 | 2 | 20.19 |
| 2019-07 | 4 | 13.37 |
| 2019-08 | 0 | 11.15 |
| 2019-09 | 0 | 11.95 |
| 2019-10 | 2 | 9.58 |
| 2019-11 | 0 | 11.88 |
| 2019-12 | 1 | 14.46 |
| 2020-01 | 0 | 11.27 |
| 2020-02 | 0 | 12.22 |
| 2020-03 | 0 | 12.88 |
| 2020-04 | 0 | 10.44 |
| 2020-05 | 0 | 15.5 |
| 2020-06 | 0 | 12.21 |
| 2020-07 | 1 | 14.34 |
| 2020-08 | 0 | 12.98 |
| 2020-09 | 0 | 12.31 |
| 2020-10 | 1 | 12.61 |
| 2020-11 | 1 | 14.12 |
| 2020-12 | 0 | 12.64 |
| 2021-01 | 1 | 11.89 |
| 2021-02 | 0 | 14.14 |
| 2021-03 | 0 | 13.25 |
| 2021-04 | 0 | 13.21 |
| 2021-05 | 0 | 14.8 |
| 2021-06 | 0 | 18.26 |
| 2021-07 | 0 | 13.79 |
| 2021-08 | 0 | 17.29 |
| 2021-09 | 0 | 24.68 |
| 2021-10 | 0 | 14.32 |
| 2021-11 | 1 | 16.72 |
| 2021-12 | 0 | 12.67 |
| 2022-01 | 1 | 10.59 |
| 2022-02 | 0 | 13.53 |
| 2022-03 | 0 | 15.09 |
| 2022-04 | 0 | 12.75 |
| 2022-05 | 0 | 16.55 |
| 2022-06 | 0 | 15.68 |
| 2022-07 | 1 | 12.74 |
| 2022-08 | 0 | 13.73 |
| 2022-09 | 0 | 15.67 |
| 2022-10 | 0 | 18.18 |
| 2022-11 | 0 | 16.94 |
| 2022-12 | 1 | 16.56 |
| 2023-01 | 1 | 14 |
| 2023-02 | 0 | 12.62 |
| 2023-03 | 0 | 16.68 |
| 2023-04 | 1 | 14.38 |
| 2023-05 | 0 | 16.67 |
| 2023-06 | 0 | 24.22 |
| 2023-07 | 3 | 25.39 |
| 2023-08 | 1 | 21.23 |
| 2023-09 | 0 | 17.03 |
| 2023-10 | 1 | 17.29 |
| 2023-11 | 0 | 18.43 |
| 2023-12 | 2 | 20.54 |
| 2024-01 | 0 | 25.65 |
| 2024-02 | 0 | 20.49 |
| 2024-03 | 0 | 21.69 |
| 2024-04 | 0 | 22.32 |
| 2024-05 | 0 | 18.44 |
| 2024-06 | 0 | 19.81 |
| 2024-07 | 1 | 23.6 |
| 2024-08 | 0 | 29.73 |
| 2024-09 | 0 | 22.75 |
| 2024-10 | 1 | 27.4 |
| 2024-11 | 0 | 14.37 |
| 2024-12 | 1 | 16.74 |
| 2025-01 | 0 | 16.27 |
| 2025-02 | 0 | 21.38 |
| 2025-03 | 0 | 25.24 |
| 2025-04 | 0 | 23.34 |
| 2025-05 | 0 | 20.44 |
| 2025-06 | 0 | 33.41 |
| 2025-07 | 0 | 20.35 |
| 2025-08 | 0 | 17.63 |
| 2025-09 | 0 | 19.99 |
| 2025-10 | 0 | 18.6 |
| 2025-11 | 0 | 16.83 |
| 2025-12 | 0 | 15.93 |
| 2026-01 | 0 | 17 |
| 2026-02 | 0 | 14.12 |
| 2026-03 | 0 | 15.06 |
| 2026-04 | 0 | 11.52 |
| 2026-05 | 0 | 11.51 |
| 2026-06 | 0 | 8.95 |
Failure-mode summaryAI-generated
33 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2017-10-16 | Z-1216-2018 | Class II | Terminated | Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in conjunction with the Stryker Navigation System because the settings on the machine were higher than intended. This change led to increased energy directed onto the tip of the Thoracic Pedicle Feeler which caused material degradation where the laser marks exist. There is the potential for the tip of the Thoracic Pedicle Feeler to break.Distribution: International , US and US Govt. | 28 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-12-03 | 0008010177-2024-00129 | Malfunction | Available | exact di |
| 2024-10-17 | 0008010177-2024-00112 | Malfunction | Available | exact di |
| 2024-07-17 | 0008010177-2024-00064 | Malfunction | Available | exact di |
| 2023-12-14 | 3015967359-2023-02604 | Malfunction | Available | exact di |
| 2023-12-14 | 3015967359-2023-02598 | Malfunction | Available | exact di |
| 2023-10-02 | 3015967359-2023-02043 | Malfunction | Available | exact di |
| 2023-08-21 | 3015967359-2023-01873 | Malfunction | Available | exact di |
| 2023-07-24 | 3015967359-2023-01485 | Malfunction | Available | exact di |
| 2023-07-21 | 3015967359-2023-01479 | Malfunction | Available | exact di |
| 2023-07-18 | 3015967359-2023-01461 | Malfunction | Available | exact di |
| 2023-04-27 | 3015967359-2023-01047 | Malfunction | Available | exact di |
| 2023-01-03 | 3015967359-2023-00002 | Malfunction | Available | exact di |
| 2022-12-28 | 3015967359-2022-02513 | Malfunction | Available | exact di |
| 2022-07-21 | 3015967359-2022-01329 | Malfunction | Available | exact di |
| 2022-01-11 | 3015967359-2022-00031 | Malfunction | Available | exact di |
Showing 1–15 of 33
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-02-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2017-07-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2013-11-14 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
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