n/a 75700450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169542907), received between Mar 26, 2021 and Jan 30, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF DUE TO POS TERIOR LUMBAR SPINAL FUSION (PERCUTANEOUS PEDICLE SCREW INSERTION.) FOR L3/4 LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT  DUE TO PERCUTANEOUS PEDICLE SCREW INSERTION INTO L3/4, THE PROCEDURE WAS ADVANCED WITH THE PROBE TO THE GUIDEWIRE, TO THE TAP, AND THE SCREW. BOTH SIDES OF L3 COULD BE INSERTED INTO THE SCREW, BUT THE LEFT PEDICLE OF L4 WAS STIFFENED. AN EVENT OCCURRED IN WHICH THE GUIDE WIRE WAS ALSO PUSHED BACK SEVERAL TIMES. THE PROBE WAS PERFORMED AGAIN. A PILOT HOLE WAS CREATED BY ATTACHING A JACOBS CHUCK TO THE K-WIRE, AND SOMEHOW THE HOLE WAS OPENED TO THE ANTERIOR BORDER OF THE VERTEBRAL BODY. AFTERWARD, THE TAP WAS CUT THROUGH THE GUIDEWIRE, BUT THE GUIDEWIRE WAS LOST INTO THE BONE AGAIN, AND THE TIP BECAME BENT INSIDE THE VERTEBRAL BODY. AN ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE WHILE THE TAP WAS TURNED BACKWARD, BUT IT COULD NOT BE REMOVED PROPERLY. IN THE END, THE TIP OF THE GUIDEWIRE WAS BROKEN BY ABOUT 5 MM AND REMAINED IN THE VERTEBRAL BODY. IT WAS DIFFICULT TO PERFORM THE SURGERY, SO IT WAS PLACED INSIDE THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16262803 ↗
• MalfunctionMar 11, 2022Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SCREW USING A GUIDEWIRE IN A TH12-S2AI POSTERIOR FIXATION (PPS) FOR AN L3 VERTEBRAL FRACTURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE WAS USED TO INSERT THE HOLLOW SCREW AND BECAME DIFFICULT TO REMOVE. THE SCREW WAS PULLED BACK AND THE GUIDEWIRE WAS REMOVED. AFTERWARDS, IT WAS REINSERTED IN A DEEPER REGION. NO SIGNS OF DAMAGE WERE OBSERVED IN THE INTRAOPERATIVE IMAGES. THE GUIDEWIRE WAS BROKEN. THE GUIDEWIRE USED TO INSERT THE HOLLOW SCREW REMAINED INSIDE OF THE ILIUM. THE REMAINING GUIDEWIRE WAS CONFIRMED BY THE PHYSICIAN ON THE POSTOPERATIVE X-RAY. AFTER CONFIRMING WITH THE PHYSICIAN, HE DETERMINED THAT THERE WERE NO PROBLEMS. A REPEAT SURGERY IS CURRENTLY NOT PLANNED. THERE IS A PLAN TO CONTINUE TO FOLLOW-UP ON WHETHER THERE ARE ANY PROBLEMS AFTER THE SURGERY. THE EVENT WAS ASSOCIATED WITH THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THIS WAS NOT A REPEAT SURGERY, THERE WAS NO DELAY IN THE OVERALL PROCEDURE TIME, NO HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION, AND NO TREATMENT OR ADDITIONA

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13730644 ↗
• MalfunctionMar 26, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR POSTERIOR FIXATION. IT WAS REPORTED THAT AFTER FILLING TWO HA 4 MM STICKS, WHEN SCREW WAS INSERTED THROUGH THE GUIDEWIRE, THE GUIDEWIRE BROKE AND REMAINED IN THE L4 LEFT VERTEBRAL BODY ABOUT 5 MM. THE DELAY IN SURGERY WAS LESS THAN 60 MINS AND THERE WERE BROKEN FRAGMENTS LEFT INSIDE THE PATIENT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED. 2021-MAR-12 : INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT DURING THE REOPERATION, WHEN 7.5 X 45 MM SCREW WAS ORIGINALLY REMOVED, THE 8.5 X 45 MM SCREW (LOT UNKNOWN) WAS INSERTED, AT THE TIME OF CHECKING THE PRODUCT BY THE SALES REP WHEN THERE WERE ABOUT TWO TURNS LEFT, AND THE REPORTED GUIDE WIRE CAME FROM THE HOLLOW SCREW TIP. WHEN CHECKING AFTER INSERTING THE SCREW, A SHORT GUIDE WIRE (ABOUT 1 CM) REMAINED IN FRONT OF THE TIP OF SCREW, AND WHEN CHECKING THE REMOVED WIRE, IT WAS DAMAGED. IT WAS UNKNOWN WHETHER THE REMAINING WIRE IS IN CONTACT WITH THE SCREW. IT WAS UNKNOWN WHETHER THE REMAINING WIRE IS IN CONTACT WITH THE SCREW. 2021-MAR-18: INFORMATION WAS RECEI

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573194 ↗