Medtronic Reusable Instruments 9412500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994683557), received between Jul 14, 2019 and Mar 25, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH L3/4 VERTEBRAL BODY COLLAPSE SUGGESTED FOR SPINAL THERAPY. POSTERIOR FIXATION WAS PERFORMED AT L1-S2. LEVELS IMPLANTED WAS L3- 4. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT L3/4 VERTEBRAL SUBTOTAL REMOVAL WAS PERFORMED AND THE REPORTED IMPLANTS WERE PLACED. THE CAGE WAS LENGTHENED AFTER BEING INSERTED BETWEEN THE VERTEBRAL BODIES, BUT IT SHRANK BEFORE IT WAS FULLY LENGTHENED. WHEN THE CAGE WAS CHECKED OUTSIDE THE OPERATIVE FIELD, IT COULD BE LENGTHENED TO THE END WITHOUT ANY PROBLEM, BUT THE SAME EVENT WAS CONFIRMED IN THE OPERATIVE FIELD. IT WAS ATTEMPTED TO LENGTHEN THE CAGE BY INSERTING AN ADJUSTER INTO THE OPENING FOR FILLING BONE GRAFT, BUT THE CAGE COULDN'T BE LENGTHENED UNTIL THE END. THEREFORE, THE CAGE WAS REPLACED WITH ANOTHER ONE WITH ONE INCREASED SIZE. THE TORQUE LIMITING DRIVER WAS NOT USED. DELAY OF OVER 60 MINUTES WAS REPORTED. IMPLANT WAS EXPLANTED AND BEING RETURNED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WAS REPORTED. NO DEFECT WAS FOUND IN INSERTER IN APPEARANCE. LOT#CA12G066 AND CA12J027 OF PINION DRIVER HAD SCRATCHES AT TIP. CA13F029-B HAD SCR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11567328 ↗
• MalfunctionJul 14, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT INTRA-OP, WHILE USING A MALLET AND ANGULATED FORCE TO MANEUVER THE IMPLANT INTO DESIRED POSITION, THE FORK TONGS OF THE INSERTER WERE BENT. THE TONGS WERE NO LONGER ABLE TO RETAIN AND LOCK THE IMPLANT. THE PROCEDURE WAS HOWEVER COMPLETED SUCCESSFULLY WITH THE SAME INSERTER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8787553 ↗