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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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 ↗

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources and updates

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