ADDplus™ anterior distraction device plus CS 2253-12-25Recalls & reported problems
Ulrich GmbH & Co. KG · ADDplus, ø 12 mm, height 25-41 mm, angle 12° · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052536009374), received between Jan 17, 2019 and Jan 17, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Most reported problems
Device problems
- Difficult to Insert1
- Material Fragmentation1
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.
InjuryJan 17, 2019Material Fragmentation; Difficult to Insert; Material Fragmentation; Difficult to Insert
THE SURGEON WAS UNABLE TO DRIVE IN THE SET SCREW. THE REP REPORTED THAT THE THREADS ON THE DEVICE APPEARED STRIPPED AND METAL PARTICLES WERE COMING OFF OF THE SCREW AND CAGE. THE CAGE WAS IMPLANTED WITH NO LOCKING SCREW.
Patient problems: Failure of Implant
MAUDE report 8256507 ↗
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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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