ANATOMIC PEEK PTC Cervical Fusion System · 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.

3 linked reportsMalfunction 3

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-02	0	1
2019-03	0	1
2019-04	0	1
2019-05	0	1.5
2019-06	0	1.17
2019-07	0	2
2019-08	0	6.67
2019-09	0	1
2019-10	0	3.56
2019-11	0	1.33
2019-12	0	1
2020-01	0	1.33
2020-02	0	2
2020-03	0	1.5
2020-04	0	1.5
2020-05	0	1.57
2020-06	0	1
2020-07	0	1.33
2020-08	0	1.42
2020-09	0	1
2020-10	0	1.58
2020-11	0	1
2020-12	0	2
2021-01	0	1.25
2021-02	0	1.5
2021-03	0	1.71
2021-04	0	1
2021-05	0	1
2021-06	0	4.05
2021-07	0	1.25
2021-08	0	1
2021-09	0	1.86
2021-10	0	1
2021-11	0	1
2021-12	0	1.38
2022-01	0	1.25
2022-02	0	1.5
2022-03	0	1.64
2022-04	0	1.2
2022-05	0	1.85
2022-06	0	1.4
2022-07	0	1.29
2022-08	0	1.43
2022-09	0	2.11
2022-10	0	1.33
2022-11	0	2
2022-12	0	1
2023-02	0	1
2023-03	0	1.57
2023-04	0	1
2023-05	0	1.5
2023-06	0	1
2023-07	0	1
2023-08	0	5.78
2023-09	0	1
2023-10	0	1.6
2023-11	0	1
2023-12	0	1.25
2024-01	0	4
2024-02	0	1.5
2024-03	0	1.5
2024-04	0	1.5
2024-05	0	1.33
2024-06	0	1.5
2024-07	0	1.67
2024-08	1	2
2024-09	0	1.67
2024-10	0	1.2
2024-11	1	1.6
2024-12	0	1.71
2025-01	0	1.43
2025-02	0	1.78
2025-03	1	1.4
2025-04	0	1.88
2025-05	0	1.25
2025-06	0	1.6
2025-07	0	2.4
2025-08	0	1.67
2025-09	0	1.33
2025-10	0	1.5
2025-11	0	1.83
2025-12	0	1.67
2026-01	0	1.38
2026-02	0	1.38
2026-03	0	1.63
2026-04	0	1.38
2026-05	0	1.71
2026-06	0	1.89

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-03-26	1030489-2025-01538	Malfunction	Available	exact di
2024-11-26	1030489-2024-01575	Malfunction	Available	exact di
2024-08-21	1030489-2024-01031	Malfunction	Available	exact di

Regulatory clearances

Predicate lineage

K133653

Cited as predicate by: K142152, K160528, K172568, K180590, K192502

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
2026-02-06	NAI	No action indicated	Medtronic Sofamor Danek USA Inc	0
2017-10-26	NAI	No action indicated	Medtronic Sofamor Danek USA, Inc	0
2015-11-03	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2015-10-23	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	1
2014-03-11	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2013-07-15	NAI	No action indicated	Medtronic Sofamor Danek USA, Inc	0
2013-07-15	NAI	No action indicated	Medtronic Sofamor Danek USA Inc	0
2012-06-06	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2011-02-23	NAI	No action indicated	Medtronic Sofamor Danek Usa Inc	0
2010-08-06	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2010-03-04	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2010-02-25	NAI	No action indicated	Medtronic Sofamor Danek USA Inc	0

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