ADAPT 0101-2900Recalls & reported problems
Stryker Leibinger GmbH & Co. KG · PC Unit · Class 2
Data updated Oct 16, 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 07613327312393), received between Dec 5, 2019 and Dec 5, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Image Display Error/Artifact” (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 16, 2026.
Most reported problems
Device problems
- Image Display Error/Artifact1
- Incorrect Measurement1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2019Image Display Error/Artifact; Incorrect Measurement; Image Display Error/Artifact; Incorrect Measurement
DURING TESTING OF THE DEVICE, SIGNIFICANT MISREPRESENTATIONS AND MISMEASUREMENTS OCCURRED. THE DEVICE IS REPORTED TO BE NEW. SURGICAL DELAY OF 30MIN. NOT LONGER. THIS RESULTED IN TRIPLE INCREASE IN RADIATION EXPOSURE, NORMALLY RADIATION TIME FOR GAMMA3 NAIL IN THIS HOSPITAL IS 12-13 SECONDS, IN THIS SURGERY 40 SECONDS. NO OTHER PATIENT IMPACT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9417005 ↗
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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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