NA 02.221.154SRecalls & reported problems
Synthes GmbH · 3.5MM VA PPFX DSTL FEMUR SPAN ATTCHMT PL/6H/RIGHT/STER · Class 2 · Implant
Data updated Oct 18, 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 10886982276582), received between Sep 6, 2024 and Sep 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Post Operative Wound Infection1
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2024Off-Label Use; Off-Label Use
THIS COMPLAINT IS FROM A DATA USE AGREEMENT (DUA). THE DUA SUMMARIZES 14 PATIENTS THAT WERE IMPLANTED WITH 3.5/4.5 MM VA-LCP PERIPROSTHETIC PROXIMAL FEMUR PLATING SYSTEM. IMPLANTATION WAS BETWEEN DECEMBER 2021 TO APRIL 2024 AT WAKE FOREST UNIVERSITY HEALTH SYSTEMS. PATIENT NUMBER 10 (56-YEAR-OLD FEMALE) - HISTORY OF DDD, ANKLE ARTHRITIS, LUMBAR RADICULOPATHY & SPONDYLOSIS. IMPLANTS WERE PLACED DUE TO PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. POST-OP COMPLICATION FOR POST-OP WOUND INFECTION AND DEHISCENCE. THIS IS RELATED TO THE PROCEDURE. TREATMENT INCLUDED SURGICAL INTERVENTION AND ANTIBIOTICS. THE PATIENT REPORTED USING THE DISTAL SPANNING ATTACHING PLATE (DSAP) WITH THE DEPUY CURVE CONDYLAR PERIARTICULAR PLATE FOR A PROXIMAL FEMUR PERIPROSTHETIC FRACTURE. THE DSAP WAS NOT DESIGNED FOR USAGE WITH THIS PARTICULAR PLATE; THUS, THIS CASE WAS CONSIDERED OFF-LABEL.
Patient problems: Post Operative Wound Infection; Wound Dehiscence
MAUDE report 20158179 ↗
Other Plate, fixation, bone devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-MLT42Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- PRECICE® Plating System LP4.5-MRT42Nuvasive 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page