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OVERWATCH 108-107-01-SCRecalls & reported problems

Spinal Elements · Quick Lock Screw Driver, Short Cannulated Inner Shaft · Class 1

All models of OVERWATCH (10)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840916134778), received between Oct 22, 2019 and Oct 22, 2019 — 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 18, 2026.

Most reported problems

Device problems

  • Fracture1
  • Mechanical Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionOct 22, 2019Fracture; Mechanical Problem; Fracture; Mechanical Problem

    WHILE DRIVING THE PEDICLE BONE SCREW AND REPORTEDLY BURYING IT INTO SCLEROTIC BONE, SURGEON HEARD A POP. 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 OR FUTURE INJURY ANTICIPATED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9218563 ↗

Other Screwdriver devices

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Sources and updates

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