uNion MAX UU202-03-0004Recalls & reported problems
Ulrich Medical Usa, Inc. · T15 Screwdriver Removable Shaft · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810076333762), received between Oct 27, 2025 and Nov 21, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 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
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2025Break; Break
SCREW DRIVER TIP BROKE DURING SURGERY. IT WAS REPORTED THE SURGEON DID DRILL PRIOR TO IMPLANTING THE SCREW BUT THE BONE WAS HARD. THE SCREW AND DRIVER TIP WERE REMOVED AND A NEW SCREW WAS INSTALLED WITHOUT FURTHER PROBLEMS. THE EXPLANTED SCREW AND TIP WERE THROWN AWAY AT THE SURGICAL CENTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23624721 ↗MalfunctionNov 21, 2025Break; Break
SCREW DRIVER TIP BROKE DURING SURGERY. IT WAS REPORTED THE SURGEON DID DRILL PRIOR TO IMPLANTING THE SCREW BUT THE BONE WAS HARD. THE SCREW AND DRIVER TIP WERE REMOVED AND A NEW SCREW WAS INSTALLED WITHOUT FURTHER PROBLEMS. THE EXPLANTED SCREW AND TIP WERE THROWN AWAY AT THE SURGICAL CENTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23623478 ↗MalfunctionOct 27, 2025Break; Break
SCREWDRIVER TIP BROKE DURING SURGERY. IT WAS REPORTED THE SURGEON DID DRILL PRIOR TO IMPLANTING THE SCREW BUT THE BONE WAS HARD. THE SCREW AND DRIVER TIP WERE REMOVED AND A NEW SCREW WAS INSTALLED WITHOUT FURTHER PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23394684 ↗
Other Appliance, Fixation, Spinal Intervertebral Body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- Mariner RDX MX1-000040Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Mariner RDX MX1-000030Seaspine Orthopedics Corporation · Appliance, fixation, spinal intervertebral body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430112Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- Elegance® Anterior Cervical Plate 53430224Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 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