OVERWATCH 108-157-01Recalls & reported problems
Spinal Elements · OVERWATCH® N Driver Inner Shaft · Class 2
- 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 00840916134839), received between Dec 15, 2023 and Dec 15, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Movement1
- Unintended System Motion1
Patient problems
- Vertebral Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2023Unintended System Motion; Unintended Movement; Unintended System Motion; Unintended Movement
REPORTEDLY DURING A TLIF SPINAL FUSION SURGERY WITH POSTERIOR FIXATION (L2- S1), A PEDICLE BONE SCREW FRACTURED/CRACKED THE PEDICLE BONE L3 ON (B)(6) 2023. ALLEGEDLY THE DRIVER OR DRIVER SLEEVE WAS BENT. THE DEVICE WOBBLED AND HAD A DIFFERENT TRAJECTORY AND/OR DIFFERENT STARTING POINT, WHEN ADVANCING THE SCREW. THIS CONDITION ALLEGED CAUSED A CRACKED/FRACTURE IN THE PEDICLE BONE. NO ADDITIONAL MEDICAL INTERVENTION WAS TAKEN. PATIENT IS ASYMPTOMATIC AND THERE IS NO PLAN FOR REVISION SURGERY.
Patient problems: Vertebral Fracture
MAUDE report 18340772 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.