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Precept 8805545ARecalls & reported problems

Nuvasive, Inc. · PRECEPT Screw, 5.5x45mm Polyaxial · 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 00887517449764), received between Jul 28, 2016 and Jul 28, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1

Patient problems

  • Failure of Implant1
  • Fall1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 28, 2016Fracture; Fracture

    ON (B)(6) 2015 A FEMALE PATIENT HAD A PEDICLE SCREW SYSTEM PLACED AT L4-L5. REPORTEDLY THE PATIENT SUSTAINED A FALL AND ONE OF THE PEDICLE SCREWS HAS BROKEN. THE SURGEON HAS ELECTED TO MONITOR THE PATIENT. NO REVISION SURGERY IS SCHEDULED AT THIS TIME.

    Patient problems: Failure of Implant; Fall

    MAUDE report 5831239 ↗

Other APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices

All APPLIANCE, FIXATION, SPINAL INTERLAMINAL devices →

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