N/A 6640008Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169492493), received between May 28, 2021 and Jun 6, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING THE IMPLANTATION OF A SCREW IN A SPINAL PROCEDURE, THE TIP OF THE SCREWDRIVER BROKE OFF IN THE SCREW HEAD AND COULD NOT BE RETRIEVED. IT WAS THEN DETERMINED THAT THE BROKEN TIP SHOULD REMAIN IN PLACE, AND RODS AND SET SCREWS WERE SUBSEQUENTLY PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159350 ↗
• MalfunctionSep 9, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20166467 ↗
• MalfunctionAug 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A SPINAL PRODUCT USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT DURING THE FIRST SCREW IMPLANTATION PROCEDURE (L4), THE SCREWDRIVER WAS BROKEN AND STUCK INTO SCREW HEAD AND CANNOT BE TAKEN OUT. WHEN ANOTHER SCREW WAS IMPLANTED, THE OTHER DRIVER WAS BROKEN. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS NO MALFUNCTION ASSOCIATED WITH THE SCREWS. BROKEN FRAGMENTS OF DRIVERS WAS LEFT INSIDE THE PATIENT AS SURGEON FAILED TO PULL OUT THE SCREWS DUE TO PATIENT'S HIGH BONE DENSITY. THERE IS NO REVISION SURGERY WAS SCHEDULED OR PLANNED AS THE SCREW WAS TOO HARD TO UNSCREW DURING THE SURGERY, AND THE MRI/CT IMAGE SHOWED THE SCREW AND ROD WERE STABLE (2 DAY AFTER SURGERY).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15202299 ↗
• MalfunctionMay 28, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SCREWS USING A SCREWDRIVER FOR A TLIF. IT WAS REPORTED THAT TIP OF SCREW DRIVER BROKE DURING INSERTION OF SCREWS INSIDE SCREW CORE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PRE-OP DIAGNOSIS WAS DDD AND LEVELS IMPLANTED WERE L4 <(>&<)> L5. THE PRODUCT DID NOT COME IN CONTACT WITH THE PATIENT. THERE WAS NO FRAGMENT OF THE INSTRUMENT REMAINING IN THE PATIENT 'S BODY. THE EVENT OCCURRED DURING THE MIDDLE OF SURGERY. THERE WAS NO ADDITIONAL SURGERY OR TREATMENT/ REVISION SURGERY/ DELAY IN OVERALL PROCEDURE TIME/ HOSPITALIZATION AS A RESULT OF THE EVENT. THE PRODUCT WILL NOT BE REPLACED BY A MEDTRONIC PRODUCT IN THE FUTURE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899517 ↗