N/A 7485250Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074138473), received between Feb 24, 2025 and Feb 24, 2025 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 24, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A PROCEDURE BEFORE USING ON PATIENT, A BROKEN SCREWDRIVER WAS IDENTIFIED. THE PROCEDURE INVOLVED THE PATIENT IN VENTRAL RECUMBENCY WITH ASEPTIC TECHNIQUE, MIDLINE INCISION, DISSECTION BY PLANES, HEMOSTASIS, SUBPERIOSTIC DISSECTION FROM T3 TO L3, PLACEMENT OF PEDICULAR SCREWS, AND ADJUSTMENT AND CORRECTION OF KYPHOSIS. RADIOSCOPY VERIFICATION WAS PERFORMED, AND THERE WAS NO ALTERATION OF EVOKED POTENTIAL. THE PROCEDURE ALSO INCLUDED DECORTICATION OF THE SHEET, PLACEMENT OF BONE SUBSTITUTE AND AUTOLOGOUS MATERIAL, DRAINAGE PLACEMENT, AND CLOSURE BY PLANS. THE INSTRUMENT BREAKAGE DID NOT RESULT IN ANY INJURY TO THE PATIENT, DID NOT EXTEND HOSPITALIZATION, AND DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT. NO FRAGMENTS OF THE INSTRUMENT REMAINED IN THE PATIENT AND NO FURTHER COMPLICATIONS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21444180 ↗