uNion MAX UU201-01-0013Recalls & reported problems
Ulrich Medical Usa, Inc. · High Angulation Plate, 1-Level, 13 mm · Class 2 · Implant
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 00810076334400), received between Mar 11, 2026 and Mar 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2026Break
DURING THE CASE THE SURGEON WAS TURNING THE CAM TO COVER THE SCREW HEADS AND THE CAM DISASSOCIATED FROM THE PLATE. THE PLATE WAS REPLACED WITH A NEW ONE. THE PLATE HAS NOT YET BEEN RETURNED TO THE COMPANY. THERE WAS NO HARM TO THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 24568899 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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