N/A 5584922Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169163041), received between Nov 20, 2018 and May 17, 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.

• MalfunctionMay 17, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE TIP OF 4 DRIVERS WAS BROKEN WHEN PEDICLE SCREW WAS INSERTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WERE NO FRAGMENTS OF THE IMPLANTS OR INSTRUMENTS REMAINED IN THE PATIENT'S BODY. THERE WAS A DELAY OF LESS THAN 60MIN IN OVERALL PROCEDURE TIME. THE SCREW PLACEMENT WAS COMPLETED AND THE OPERATION HAD BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830651 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL STENOSIS AND DEGENERATIVE DISC DISEASE AND UNDERWENT MINIMALLY INVASIVE SPINE (MIS) FIXATION SURGERY AT L4- S1 LEVELS. DURING SURGERY, THE TIP OF THE DRIVER BROKE. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8093417 ↗