Precept 8847065Recalls & reported problems
Nuvasive, Inc. · PRECEPT Ti Rod, 65mm Prebent Lordotic · Class 2 · Implant
All models of Precept (21)
Data updated Oct 16, 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 00887517377586), received between Mar 14, 2016 and Mar 14, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Mechanical Problem1
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 14, 2016Detachment Of Device Component; Mechanical Problem; Detachment Of Device Component; Mechanical Problem
ON (B)(6) 2016 A REVISION PROCEDURE WAS PERFORMED REPLACING BOTH RODS, BONE SCREW AND LOCKSCREW AT RIGHT-SIDE S1 WITH NO REPORTED COMPLICATIONS. ON (B)(6) 2016 DURING A FOLLOW UP VISIT RADIOGRAPHIC IMAGES SHOWED ROD SEPARATION AT S1. NO PATIENT INJURY HAS BEEN REPORTED. REVISION IS NOT PLANNED AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 5498975 ↗
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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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