BL-OSC-HRecalls & reported problems
Z-Systems AG · Ceramic Basal Screw, incl. single-use screwdriver · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07640166760870), received between Jan 31, 2025 and Apr 30, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration3
- Fracture1
Patient problems
- Unspecified Tissue Injury3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2025Fracture; Fracture
InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.