InCompass Spinal Fixation System 2155-4Recalls & reported problems
Highridge Medical, LLC · Universal Driver - Modular · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03662663192361), received between Dec 22, 2025 and Dec 22, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE SCREW DRIVERS (ONE UNIVERSAL AND TWO UNIVERSAL WITH STANDARD CONNECTIONS) BROKE INTRA-OPERATIVELY WHILE ATTEMPTING TO REMOVE A SCREW THAT HAD BEEN IMPLANTED FOR 16 YEARS. THE SCREW WAS ABLE TO BE REMOVED USING AN ALTERNATIVE METHOD SINCE THE DRIVER ENGAGEMENT FEATURE HAD STRIPPED. THERE WERE NO REPORTED IMPACTS TO THE PATIENT. THIS IS REPORT THREE OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871747 ↗MalfunctionDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT THE TIPS OF THREE SCREW DRIVERS (ONE UNIVERSAL AND TWO UNIVERSAL WITH STANDARD CONNECTIONS) BROKE INTRA-OPERATIVELY WHILE ATTEMPTING TO REMOVE A SCREW THAT HAD BEEN IMPLANTED FOR 16 YEARS. THE SCREW WAS ABLE TO BE REMOVED USING AN ALTERNATIVE METHOD SINCE THE DRIVER ENGAGEMENT FEATURE HAD STRIPPED. THERE WERE NO REPORTED IMPACTS TO THE PATIENT. THIS IS REPORT TWO OF THREE FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871677 ↗
Other SCREWDRIVER devices
- DELTA XTEND 2307-92-003Depuy (Ireland) · SCREWDRIVER751 reports
- EXPEDIUM 279712400Medos International Sàrl · SCREWDRIVER551 reports
- NA 314.467Synthes GmbH · SCREWDRIVER498 reports
- N/A 5584111Medtronic Sofamor Danek, Inc. · SCREWDRIVER492 reports
- QUICKSET 2274-47-000Depuy (Ireland) · SCREWDRIVER487 reports
- NA 03.130.010Synthes GmbH · SCREWDRIVER1 recall422 reports
- QUICKSET 2274-63-000Depuy (Ireland) · SCREWDRIVER404 reports
- EVOS 71175072Smith & Nephew, Inc. · SCREWDRIVER336 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page