VA-LCP 02.118.408Recalls & reported problems
Synthes GmbH · 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/7 HOLES/RIGHT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982038944), received between Jan 12, 2021 and Aug 22, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (2 reports).
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.
Most reported problems
Device problems
- Material Twisted/Bent2
- Contamination /Decontamination Problem1
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 22, 2022Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2022, THE SALES REP WAS PUTTING THE DEVICES TOGETHER AND NOTICED SIGNIFICANT DIFFERENCES IN THE FINISHES. THE FINISHING ON THE ANTERO LATERAL AND DISTAL FIBULA PLATES DO NOT LOOK CONFORMING WHEN COMPARED TO THE SMOOTH FINISHING OF THE MEDIAL DISTAL PLATE. IT WAS REPORTED AS LOOKING LIKE THERE WAS A WATER MARK THAT COULD NOT BE RUBBED OFF. THERE WAS NO REPORTED PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/7 HOLES/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15266354 ↗MalfunctionFeb 3, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2021, AN UNKNOWN PROCEDURE WAS PERFORMED, RIA 2 WAS USED WITH REAMER HEAD AND THE TUBING SCRUNCHED UP DUE TO EXCESSIVE FORCE. THE REAMER HEAD BROKE. ON THE IPSILATERAL SIDE A DYNAMIC HIP SYSTEM (DHS) WAS INSERTED BUT THE LAG SCREW WAS RIPPED DURING INSERTION. ON THE CONTRALATERAL SIDE TWO DISTAL FIBULA PLATES ENDED UP CROSS THREADING THE VARIABLE ANGLE (VA) LOCKING HOLES. THERE WAS A SURGICAL DELAY OF 10 MINUTES. CONCOMITANT DEVICES REPORTED: RIA 2 BONE HARVESTING KIT 520MM STERILE (PART NUMBER 03.404.000S, LOT UNKNOWN, QUANTITY 1). 10.0MM REAMER HEAD FOR RIA 2 STERILE (PART NUMBER 03.404.016S, LOT UNKNOWN, QUANTITY 1). DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/95MM (PART NUMBER 280.295, LOT UNKNOWN, QUANTITY 1). 2.0MM THRDD GUIDE F/ 2.7MM SCR VA AND LCP (PART NUMBER 03.133.008, LOT UNKNOWN, QUANTITY 1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/LEFT (PART NUMBER 02.118.405, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/7 HOLES/RIGHT. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11272462 ↗MalfunctionJan 12, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON UNKNOWN DATE IN 2020, THREE (3) VA-LCP PLATES WERE STRIPPED DURING THE PROCEDURE. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/7 HOLES/RIGHT. THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11156217 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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