uNion MAX UU201-02-0028Recalls & reported problems
Ulrich Medical Usa, Inc. · High Angulation Plate, 2-Level, 28 mm · Class 2 · Implant
Data updated Oct 18, 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 00810076334547), received between Oct 7, 2024 and Jan 23, 2026 — classified as 2 malfunctions.
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
- Improper or Incorrect Procedure or Method1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Break
DURING THE CASE THE SURGEON WAS REMOVING THE PLATE TO TAMP BACK (REPOSITION) ONE OF THE INTERBODIES. ONCE HE PUT THE PLATE BACK IN PLACE ONE OF THE CAMS DISASSOCIATED FROM THE PLATE WHILE IT WAS BEING TURNED. THE CAM CAME OFF WITH THE DRIVER. THE PLATE WAS REPLACED WITH A NEW ONE AND ALL PARTS WERE RETRIEVED. THERE WAS NO HARM TO THE PATIENT.
Patient problems: Failure of Implant
MAUDE report 24168064 ↗MalfunctionOct 7, 2024Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event
PATIENT WAS NOT EXPERIENCING ANY ISSUES, BUT CAME IN FOR STANDARD POST-OP FOLLOW UP. AFTER THE SCAN, THE SURGEON NOTICED THAT ONE OF THE SCREWS WAS BACKING OUT. WHEN ASKED, THE SURGEON THINKS THAT HE TURNED THE LOCKING CAM BUT WAS UNCERTAIN. THIS WAS A MALFUNCTION, NO SERIOUS INJURY. THE SCREW WAS LEFT IN PLACE NO INTERVENTION OR REVISION IS NEEDED AT THIS TIME. IF CIRCUMSTANCES SHOULD CHANGE A FOLLOW UP WILL BE ISSUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20392087 ↗
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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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