Precept 8806550ARecalls & reported problems
Nuvasive, Inc. · PRECEPT Screw, 6.5x50mm Polyaxial · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517450661), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2019Break; Break
ON (B)(6) 2018, PATIENT UNDERWENT A SPINAL PROCEDURE DUE TO A FRACTURE AT THE T12 LEVEL. THE PATIENT RECEIVED INSTRUMENTATION FROM T11-L1. ON 2/15/2019, IT WAS REPORTED SHANK BROKE AWAY FROM THE TULIP HEAD. A REVISION PROCEDURE HAS NOT BEEN PERFORMED AT THIS TIME. NO PATIENT INJURY HAS BEEN REPORTED.
Patient problems: Failure of Implant
MAUDE report 8396667 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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