osmium™, ADDplus™ CS 1300-16TRecalls & reported problems
Ulrich GmbH & Co. KG · osmium screw incl. bolt, green, ø 5.0 mm, length 16 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 04052536002443), received between Jun 28, 2019 and Jun 28, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- 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.
MalfunctionJun 28, 2019Material Fragmentation; Material Fragmentation
OSMIUM SCREW BOLT BROKE OFF AT TOP OF HEAD DURING INITIAL SURGERY. THE THREADED PORTION REMAINED IN THE SHAFT OF THE SCREW AND THE BROKEN HEAD WAS RETRIEVED.
Patient problems: Failure of Implant
MAUDE report 8745577 ↗
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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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