NA 281.869Recalls & reported problems
Synthes GmbH · TROCHANTER STABILIZATION PLATE 138MM · 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 10886982177940), received between Nov 12, 2019 and Nov 12, 2019 — 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
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO INFECTION AND A MALUNION. THE SURGEON STATED THAT THERE WAS NO COMPLAINT ABOUT THE DEVICE AND THAT THE OPERATING SURGEON IN (B)(6) IN 2018 MAL REDUCED THE FRACTURE WHICH LED TO RE-OPERATION. THE PROCEDURE WAS THEN COMPLETED. THE PATIENT WILL RETURN IN 6 WEEKS FOR THE INSERTION OF AN UNKNOWN BLADE AND AN UNKNOWN PLATE AFTER OSTEOTOMY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS IS 2 OF 3 FOR REPORT (B)(4).
Patient problems: No Code Available; Unspecified Infection
MAUDE report 9311984 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
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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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