NA 241.38Recalls & reported problems
Synthes GmbH · ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/97MM · Class 2 · Implant
Data updated Oct 16, 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 10886982166906), received between Nov 1, 2021 and Nov 1, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A HARDWARE REMOVAL FROM THEIR LEFT PELVIS AND LEFT ANKLE DUE TO PAIN. TWO (2) WASHERS WERE RETAINED IN THE PATIENT¿S PELVIS. THE SURGEON REMOVED 7.3MM CANNULATED SCREWS FROM THE PELVIS FROM THE LEFT ANKLE FOUR (4) PLATES AND 28 SCREWS WERE REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS LINKED TO (B)(4). THIS REPORT IS FOR ONE (1) ONE-THIRD TUBULAR PLATE WITH COLLAR 8 HOLES/97MM. THIS IS REPORT 2 OF 20 FOR (B)(4).
Patient problems: Pain
MAUDE report 12728650 ↗
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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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