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Precept 8847045Recalls & reported problems

Nuvasive, Inc. · PRECEPT Ti Rod, 45mm Prebent Lordotic · Class 2 · Implant

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 00887517377548), received between Dec 22, 2015 and Dec 22, 2015 — 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. How this data works · Data updated Oct 13, 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.

  • MalfunctionDec 22, 2015Detachment Of Device Component; Mechanical Problem

    ON (B)(6) 2015 A PATIENT UNDERWENT A PROCEDURE TO IMPLANT POSTERIOR FIXATION FROM L1 TO S1. NO PROBLEMS WERE NOTED DURING THE PROCEDURE, HOWEVER IMMEDIATE POST-OP FILMS SHOWED A POSSIBLE ROD SEPARATION AT LEFT S1. NO REVISION IS PLANNED AT THIS TIME AND NO PATIENT INJURY WAS REPORTED.

    Patient problems: Failure of Implant

    MAUDE report 5320450 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.