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.
11 linked reportsMalfunction 11
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.54 |
| 2019-02 | 0 | 1.22 |
| 2019-03 | 0 | 1.69 |
| 2019-04 | 0 | 1.46 |
| 2019-05 | 0 | 1.6 |
| 2019-06 | 0 | 1.57 |
| 2019-07 | 0 | 1.65 |
| 2019-08 | 0 | 1.36 |
| 2019-09 | 0 | 1.32 |
| 2019-10 | 0 | 1.83 |
| 2019-11 | 0 | 1.58 |
| 2019-12 | 0 | 1.36 |
| 2020-01 | 0 | 1.67 |
| 2020-02 | 0 | 1.73 |
| 2020-03 | 0 | 1.45 |
| 2020-04 | 0 | 1.43 |
| 2020-05 | 0 | 1.64 |
| 2020-06 | 0 | 1.84 |
| 2020-07 | 0 | 1.85 |
| 2020-08 | 0 | 1.63 |
| 2020-09 | 0 | 2.52 |
| 2020-10 | 0 | 2.05 |
| 2020-11 | 0 | 2.1 |
| 2020-12 | 0 | 1.76 |
| 2021-01 | 0 | 1.7 |
| 2021-02 | 0 | 1.72 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 1.55 |
| 2021-05 | 0 | 1.6 |
| 2021-06 | 0 | 2.23 |
| 2021-07 | 0 | 1.73 |
| 2021-08 | 0 | 2.21 |
| 2021-09 | 0 | 1.72 |
| 2021-10 | 0 | 2.11 |
| 2021-11 | 0 | 1.84 |
| 2021-12 | 0 | 2.54 |
| 2022-01 | 0 | 3.14 |
| 2022-02 | 0 | 2.62 |
| 2022-03 | 0 | 1.78 |
| 2022-04 | 0 | 1.76 |
| 2022-05 | 0 | 2.13 |
| 2022-06 | 0 | 1.79 |
| 2022-07 | 0 | 2.21 |
| 2022-08 | 0 | 1.86 |
| 2022-09 | 0 | 1.78 |
| 2022-10 | 0 | 1.87 |
| 2022-11 | 0 | 1.93 |
| 2022-12 | 0 | 1.7 |
| 2023-01 | 0 | 2.44 |
| 2023-02 | 0 | 2.05 |
| 2023-03 | 0 | 1.71 |
| 2023-04 | 0 | 1.81 |
| 2023-05 | 0 | 2.04 |
| 2023-06 | 0 | 1.75 |
| 2023-07 | 0 | 2.04 |
| 2023-08 | 0 | 1.73 |
| 2023-09 | 0 | 1.97 |
| 2023-10 | 0 | 1.85 |
| 2023-11 | 0 | 10.03 |
| 2023-12 | 0 | 3.95 |
| 2024-01 | 0 | 1.86 |
| 2024-02 | 0 | 2.13 |
| 2024-03 | 0 | 1.9 |
| 2024-04 | 0 | 1.36 |
| 2024-05 | 0 | 1.58 |
| 2024-06 | 0 | 1.79 |
| 2024-07 | 0 | 1.93 |
| 2024-08 | 0 | 2.27 |
| 2024-09 | 0 | 1.9 |
| 2024-10 | 0 | 2.13 |
| 2024-11 | 0 | 1.74 |
| 2024-12 | 0 | 1.69 |
| 2025-01 | 0 | 1.85 |
| 2025-02 | 0 | 1.66 |
| 2025-03 | 0 | 1.66 |
| 2025-04 | 0 | 1.6 |
| 2025-05 | 0 | 1.65 |
| 2025-06 | 0 | 2.02 |
| 2025-07 | 0 | 1.81 |
| 2025-08 | 0 | 1.61 |
| 2025-09 | 0 | 1.59 |
| 2025-10 | 0 | 1.71 |
| 2025-11 | 9 | 2.03 |
| 2025-12 | 0 | 1.85 |
| 2026-01 | 2 | 1.94 |
| 2026-02 | 0 | 1.53 |
| 2026-03 | 0 | 2.76 |
| 2026-04 | 0 | 1.57 |
| 2026-05 | 0 | 1.58 |
| 2026-06 | 0 | 1.6 |
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-10-29 | Z-1038-2026 | Class II | Open, Classified | Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.Distribution: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA. | 44 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-01-16 | 1000432246-2026-00001 | Malfunction | Available | exact di |
| 2026-01-16 | 1000432246-2026-00002 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00027 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00031 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00029 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00030 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00032 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00033 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00028 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00034 | Malfunction | Available | exact di |
| 2025-11-24 | 1000432246-2025-00035 | Malfunction | Available | exact di |
Regulatory clearances
Predicate lineage
- K241164
- K163595
- K192502
- K083026
- K091813
- K100175
- K100214
- K110543
- K111264
- K112405
- K112444
- K113528
- K113642
- K121982
- K122037
- K123978
- K130177
- K131669
- K132700
- K132897
- K133205
- K133216
- K133645
- K133650
- K133653
- K141599
- K142450
- K142559
- K150135
- K151128
- K152277
- K153373
- K160418
- K160528
- K162212
- K162680
- K171031
- K171107
- K172199
- K172328
- K173125
- K181328
- K182885
- K183510
- K190165
- K190959
- K192018
- K201267
Cited as predicate by: K253577
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 | Citations |
|---|---|---|---|---|
| 2017-02-16 | VAI | Voluntary action indicated | Medicrea International | 5 |
| 2013-06-20 | VAI | Voluntary action indicated | Medicrea International | 0 |
| 2013-06-19 | VAI | Voluntary action indicated | Medicrea International | 5 |
Similar devices
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
- Anyplus Peek Cage System GS Medical Co., Ltd.
Select up to two to place side-by-side with this device.