Cohere 8221050P2Recalls & reported problems
Nuvasive, Inc. · COHERE XLW, 10x22x50mm 10° · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517983220), received between Oct 23, 2024 and Oct 23, 2024 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE AMS IN XLIF STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT AN EXTREME LATERAL INTERBODY FUSION PROCEDURE AT L4/5. DURING THE PROCEDURE AN INCIDENTAL DUROTOMY OF RIGHT L4/L5. NEURO PATTY USING HIGH SPEED BURR. FLUOROSCOPIC IMAGING DID NOT SHOW RESIDUAL PATTY IN WOULD BED. SMALL TACHOSIL PATCH PLACED ON DURA. TISSELL PLACED ON TOP OF TACHOSIL PATCH. NO ADDITIONAL ISSUES REPORTED.
Patient problems: Laceration(s)
MAUDE report 20516901 ↗
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- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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