ReLine D10000482Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887517995452), received between Jan 26, 2024 and Jan 26, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A POSTERIOR FIXATION PROCEDURE WHILE FINAL TIGHTENING A LOCK SCREW AT RIGHT L4, THE DRIVER TIP FRACTURED OFF AND LODGED WITHIN THE LOCK SCREW. THE FRACTURE REPORTEDLY OCCURRED AFTER THE ASSOCIATED TORQUE LIMITING HANDLE DID NOT RELEASE THE TORQUE AS EXPECTED, RESULTING IN THE SURGEON USING BOTH HANDS ON THE TORQUE HANDLE TO TIGHTEN THE LOCK SCREW AND LEADING TO THE SUBSEQUENT TIP FRACTURE. AFTER AN UNSUCCESSFUL ATTEMPT TO REMOVE THE FRACTURED TIP WITH A MAGNET, THE SURGEON DECIDED TO LEAVE THE TIP IN-SITU, LODGED WITHIN THE LOCK SCREW, AND PROCEED WITH THE PROCEDURE. THERE HAS BEEN NO REPORT OF ADVERSE PATIENT IMPACT AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18592058 ↗