osmium™, ADDplus™ CS 1303-12Recalls & reported problems
Ulrich GmbH & Co. KG · osmium screw incl. bolt grey, Ø 4.0 mm, length 12 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04052536090570), received between Dec 26, 2018 and Jun 28, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Migration2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2019Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
POST OP X-RAYS REVEALED THE ADDPLUS SCREWS BACKED OUT FROM THE SUPERIOR ENDPLATE AND THE CONSTRUCT MIGRATED OUT OF PLACE. REPORT 2/2.
Patient problems: Failure of Implant
MAUDE report 8745568 ↗InjuryDec 26, 2018Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
POST OP X-RAYS REVEALED THE ADDPLUS SCREWS BACKED OUT FROM THE SUPERIOR ENDPLATE AND THE CONSTRUCT MIGRATED OUT OF PLACE.
Patient problems: Failure of Implant
MAUDE report 8197763 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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