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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.

14 linked reportsInjury 14
12342019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 2 reports for this device; peer average 2/device2019-07: 2 reports for this device; peer average 1.5/device2019-08: 2 reports for this device; peer average 1.5/device2020-01: 2 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-08: 2 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.5/device2021-09: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 4/device2022-07: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2023-10: 2 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 2/device2026-06: 2 reports for this device; peer average 2/device0204050708010208091002030901071010030607040708091001030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0401
2019-0522
2019-0721.5
2019-0821.5
2020-0122
2020-0201
2020-0822
2020-0903
2020-1003
2021-0202
2021-0301.5
2021-0902
2022-0104
2022-0702
2022-1002
2023-1022
2024-0302
2024-0602
2024-0702
2025-0402
2025-0701
2025-0801
2025-0902
2025-1003
2026-0101
2026-0303
2026-0502
2026-0622
This device (reports/month)Average device in NEK, NPZ (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2018-09-27Z-0440-2019Class IITerminatedThe Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.Distribution: US138 unitsclearance family
2013-05-28Z-1590-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.Distribution: Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.8884 unitsclearance family
2013-05-28Z-1591-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.Distribution: Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.4885 unitsclearance family
2013-05-28Z-1592-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.Distribution: Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.16994 unitsclearance family
2013-05-28Z-1589-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.Distribution: Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.22936 unitsclearance family
2013-05-28Z-1594-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.Distribution: Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.400 unitsclearance family
2013-05-28Z-1595-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.Distribution: Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.2090 unitsclearance family
2013-05-28Z-1593-2013Class IITerminatedKits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.Distribution: Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.1319 unitsclearance family
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-303003120897-2026-01126InjuryAvailableexact di
2023-10-091030489-2023-00686InjuryAvailableexact di
2020-08-241030489-2020-01127InjuryAvailableexact di
2020-01-301030489-2020-00114InjuryAvailableexact di
2020-01-061030489-2020-00027InjuryAvailableexact di
2019-08-271030489-2019-00944InjuryAvailableexact di
2019-08-011030489-2019-00842InjuryAvailableexact di
2019-07-281030489-2019-00834InjuryAvailableexact di
2019-07-251030489-2019-00816InjuryAvailableexact di
2019-05-091030489-2019-00520InjuryAvailableexact di
2019-05-031030489-2019-00508InjuryAvailableexact di

Showing the most recent 11 of 14 linked reports.

Regulatory clearances
  • PMAP000058Approved (APPR) · 2026-07-28 · +19 earlier decisionsclearance family
Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-02-06NAINo action indicatedMedtronic Sofamor Danek USA Inc0
2017-10-26NAINo action indicatedMedtronic Sofamor Danek USA, Inc0
2015-11-03VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
2015-10-23VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc1
2014-03-11VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
2013-07-15NAINo action indicatedMedtronic Sofamor Danek USA, Inc0
2013-07-15NAINo action indicatedMedtronic Sofamor Danek USA Inc0
2012-06-06VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
2011-02-23NAINo action indicatedMedtronic Sofamor Danek Usa Inc0
2010-08-06VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
2010-03-04VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
2010-02-25NAINo action indicatedMedtronic Sofamor Danek USA Inc0
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