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.
20 linked reportsInjury 20
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
1.5
2019-02
0
1
2019-03
0
1.33
2019-04
0
1
2019-05
0
2.2
2019-06
0
1.96
2019-07
0
1.89
2019-09
0
1
2019-10
0
3.25
2019-12
0
2.5
2020-01
0
1.83
2020-03
0
2.67
2020-04
0
1.5
2020-05
0
3
2020-06
0
1.5
2020-07
0
4.67
2020-08
0
3.11
2020-09
0
1.5
2020-10
0
2.36
2020-11
0
1.6
2020-12
0
1.5
2021-01
2
3.33
2021-02
0
1.5
2021-03
0
2.56
2021-04
0
3.33
2021-05
0
1.67
2021-06
6
2.29
2021-07
0
1.67
2021-08
2
1.83
2021-09
2
1.6
2021-11
0
3.82
2021-12
0
3
2022-01
0
3.83
2022-02
2
1.5
2022-03
0
2.5
2022-04
1
1.2
2022-05
0
1.67
2022-06
0
2.25
2022-07
0
1.5
2022-08
0
2.67
2022-09
0
1.33
2022-10
0
1.25
2022-11
2
1.6
2022-12
0
1.67
2023-01
0
4.6
2023-02
0
1.2
2023-03
0
1.43
2023-04
0
1.33
2023-05
0
1.9
2023-06
0
1.25
2023-07
2
1.5
2023-08
0
1.8
2023-09
0
1.29
2023-10
0
1.3
2023-11
0
1.75
2023-12
0
1.25
2024-01
0
2.22
2024-02
0
2.22
2024-03
0
1.68
2024-04
0
1.22
2024-05
0
2.89
2024-06
0
2.83
2024-07
0
1.6
2024-08
0
1.7
2024-09
0
1.89
2024-10
0
1.45
2024-11
0
1.88
2024-12
0
2.1
2025-01
0
2.32
2025-02
0
2.17
2025-03
0
2
2025-04
0
1
2025-05
0
1.25
2025-06
0
1.8
2025-07
0
1.8
2025-08
0
2.15
2025-09
0
1.93
2025-10
0
1.53
2025-11
0
3
2025-12
0
1.8
2026-01
0
1.73
2026-02
0
1.44
2026-03
0
1.88
2026-04
0
1.93
2026-05
0
2.38
2026-06
0
1.75
This device (reports/month)Average device in MJO (reports/device/month)
Failure-mode summaryAI-generated
20 linked report narratives available — no AI summary generated yet.
Recall history
Initiated
Recall #
Class
Status
Reason
Quantity
Link basis
2021-03-05
Z-1406-2021
Class II
Terminated
Centinel Spine learned through five customer complaints that the product was missing the "UP" etching on the superior plate of the prodisc C device. Per the Surgical Technique, the "UP" is one of the methods used to indicate the direction in which the surgeon should place the prodisc C into intradiscal space. There are also "UP" indications in the packaging and on instrumentation as additional guides to help the surgeon properly implant the device that were present for the affected product.Distribution: US Nationwide distribution in the states of CA, MD, DC, TN, GA, NC, PA, KY, NY, AZ, CO, OH, FL, MI.