N/A 5330033Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000165772), received between Mar 19, 2021 and Jun 15, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

• MalfunctionJun 15, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT FOR FUSION FROM L1-S1 SPINAL THERAPY. THE PRE-OP DIAGNOSIS WAS MENTIONED AS PULLED OUT IMPLANTS. IT WAS REPORTED THAT, THE HANDLE BROKE OFF THE BARREL. THE PRODUCT WAS USED ACCORDING TO IFU/LABELLING. THIS EVENT WAS HAPPENED DURING REVISION SURGERY. THE REASON FOR REVISION WAS NON-UNION, PULLED OUT SCREWS. THE PRODUCTS USED IN INITIAL SURGERY ARE NOT OF MEDTRONIC. THERE WERE NO PATIENT SYMPTOMS AND NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. PATIENT MEDICAL HISTORY INCLUDES REVISION AND SPINA BIFIDA. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999003 ↗
• MalfunctionMar 19, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THE RAPY. IT WAS REPORTED THAT HANDLE BROKE OFF DUE TO POUNDING AND RATCHET STOPS WORKING UNDER HIGH TORQUE. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FRAGMENTS LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. INFORMATION RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WERE NO PATIENT COMPLICATION. THERE WAS A REVISION SURGERY. INFORMATION RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCTS WERE NOT USED IN THE INITIAL SURGERY. INFORMATION RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS NO DELAY IN SURGERY AND THERAPY INVOLVED WAS SPINE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11526158 ↗