VA-LCP 02.118.210Recalls & reported problems
Synthes GmbH · 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 HOLES/RIGH · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982038463), received between Jun 25, 2018 and Jul 2, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Device-Device Incompatibility1
Patient problems
- Impaired Healing1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2025Break; Break
IT WAS REPORTED THAT THE PLATE FROM PATIENT'S ANKLE RECONSTRUCTION BROKE POSTOPERATIVELY. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2025. A NEW PLATE WAS PUT IN.
Patient problems: Insufficient Information
MAUDE report 22386916 ↗MalfunctionFeb 25, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT UNDERWENT AN UNKNOWN PROCEDURE. INTRA-OPERATIVELY, SOME OF THE LOCKING SCREWS WOULD NOT LOCK INTO THE PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 44MM (PART # 02.211.044, LOT # UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 48MM (PART # 02.211.048, LOT # UNKNOWN, QUANTITY 1); 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 42MM (PART # 02.211.042, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 HOLES/RIGHT. THIS IS REPORT 1 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11381779 ↗InjuryJun 25, 2018Break; Break
IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL OF HARDWARE AND REVISION TO TIBIAL NAIL AND BONE GRAFT ON (B)(6) 2018, DUE TO A BROKEN PLATE AND NONUNION. THE PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL TIBIA IN (B)(6) 2017 AT AN OUTSIDE FACILITY. THE PATIENT FELL APPROXIMATELY ONE MONTH LATER AND BROKE THE PLATE. ONE (1) LOCKING COMPRESSION PLATE, FIVE (5) UNKNOWN CORTEX SCREWS, ONE (1) METAPHYSEAL SCREW, FIVE (5) UNKNOWN VARIABLE ANGLE LOCKING SCREWS WERE REMOVED. FRAGMENTS WERE GENERATED FROM THE BROKEN PLATE BUT WERE EASILY REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES: 3.5 CORTEX SCREWS (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 5), 2.7 METAPHYSEAL SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), 3.5 VA LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). 2.7 VA LOCKING SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 4) THIS REPORT IS FOR A 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/12 HOLES/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Impaired Healing; No Code Available
MAUDE report 7634741 ↗
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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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