OVERWATCH 108-107-01-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840916134686), received between Jun 10, 2021 and May 8, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Fracture; Mechanical Problem

  ON (B)(6) 2026 PATIENT UNDERWENT REVISION SURGERY TO REMOVE HARDWARE FOR SPINAL FUSION SURGERY FOR ADJACENT SEGMENT DISEASE AFTER SUCCESSFUL FUSION HAD OCCURRED AT INDEX LEVEL. REPORTEDLY DUE TO THE PATIENT'S SCLEROTIC BONE AND BONE INGROWTH, THE BONE SCREW WAS FUSED TO THE BONE. INTRA-OPERATIVELY EXCESSIVE FORCE WAS USE AND THE BONE SCREWDRIVER DEVICE FRACTURED AT THE TIP. THE SURGEON ELECTED TO LEAVE THE BONE SCREW AND THE DEVICE TIP ENCASED IN THE SCREW HEAD AND COMPLETED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124977 ↗
• MalfunctionOct 12, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  WHILE DRIVING THE PEDICLE BONE SCREW, REPORTEDLY THE DRIVER TIP FRACTURED AND REMAINED IN THE HEAD OF THE SCREW SHANK. THOUGH THE DRIVER TIP WAS IDENTIFIED, THE SURGEON ELECTED TO LEAVE THE DRIVER TIP AND THE SCREW IN PLACE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12619060 ↗
• MalfunctionOct 12, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  WHILE DRIVING THE PEDICLE BONE SCREW, REPORTEDLY THE DRIVER TIP FRACTURED AND REMAINED IN THE HEAD OF THE SCREW SHANK. THOUGH THE DRIVER TIP WAS IDENTIFIED, THE SURGEON ELECTED TO LEAVE THE DRIVER TIP AND THE SCREW IN PLACE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12619010 ↗
• MalfunctionAug 2, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  WHILE DRIVING THE PEDICLE BONE SCREW, REPORTEDLY THE DRIVER TIP FRACTURED AND REMAINED IN THE HEAD OF THE RIGHT L5 SCREW SHANK. LEVELS BEING TREATED WERE T9--S2AI. THOUGH THE DRIVER TIP WAS IDENTIFIED, THE SURGEON ELECTED TO LEAVE THE DRIVER TIP AND THE SCREW IN PLACE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12264188 ↗
• MalfunctionJun 10, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  WHILE DRIVING THE PEDICLE BONE SCREW, REPORTEDLY THE DRIVER TIP FRACTURED AND REMAINED IN THE HEAD OF THE SCREW SHANK. LEVELS BEING TREATED WERE L1-S1. THOUGH THE DRIVER TIP WAS IDENTIFIED, THE SURGEON ELECTED TO LEAVE THE DRIVER TIP AND THE SCREW IN PLACE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11978438 ↗