NA 02.221.110SRecalls & reported problems
Synthes GmbH · 3.5/4.5MM VA PPFX PROX FEMUR PLATE/2HOLES/RIGHT/STERILE · 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 10886982275868), received between Jul 19, 2023 and Jul 19, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT FELL POST-OP AND BROKE THE VA PPFX GT ATTACHMENT RING FROM THE VA PPFX PROXIMAL FEMUR PLATE. THE RING ATTACHMENT BROKE INTO PIECES MF COMPLETELY DETACHED FROM THE VA PPFX PROXIMAL FEMUR PLATE. REVISION SURGERY IS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.5/4.5MM VA PPFX PROX FEMUR PLATE/2HOLES/RIGHT/STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Fall
MAUDE report 17353797 ↗
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- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
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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