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.
4 linked reportsMalfunction 4
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
1.54
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
4
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
0
2.03
2025-12
0
1.85
2026-01
0
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
This device (reports/month)Average device in MAX (reports/device/month)
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2025-08-06
Z-2554-2025
Class II
Open, Classified
Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.Distribution: Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong.
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.