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VA-LCP 02.127.250Recalls & reported problems

Synthes GmbH · 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/12H/207MM/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
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982043627), received between Apr 17, 2018 and Nov 15, 2023 — classified as 3 injuries.

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: 1 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: 0 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

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • No Code Available1
  • Nonunion/Delayed-union Bone Fracture1
  • Post Operative Wound Infection1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT HAD A REVISION SURGERY DUE TO THE NON UNION OF THE TIBIA. THE PATES WERE REMOVED AND WAS REVISED WITH A NAIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/12H/207MM/RIGHT. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

    Patient problems: Nonunion/Delayed-union Bone Fracture

    MAUDE report 18144383 ↗
  • InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED A PATIENT UNDERWENT TIBIAL HARDWARE REMOVAL ON (B)(6) 2018, DUE TO INFECTION/ COMPARTMENT SYNDROME IN THE KNEE. A VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) POSTERIOR MEDIAL PLATE AND EIGHT (8) UNKNOWN SCREWS WERE REMOVED. THE HARDWARE WAS ORIGINALLY IMPLANTED IN (B)(6) 2018. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT IS DOING WELL. IT WAS STATED THAT THE PLATE WAS NOT BELIEVED TO BE THE CAUSE OF THE PATIENT¿S INFECTION. THIS REPORT IS FOR A 3.5MM VA-LCP PROXIMAL TIBIA PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Patient problems: No Code Available; Unspecified Infection

    MAUDE report 8223452 ↗
  • InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT WAS INITIALLY TREATED ON (B)(6) 2018 WITH EXTERNAL FIXATOR APPLICATION AND FOUR COMPARTMENT FASCIOTOMY AND WOUND VAC. IRRIGATION AND DEBRIDEMENT WAS DONE ON (B)(6) 2018 AGAIN. PLANNED EXTERNAL FIXATOR REMOVAL FOR DEFINITIVE OPEN REDUCTION INTERNAL FIXATION WAS PERFORMED ON (B)(6) 2018 AND THE PATIENT WAS IMPLANTED WITH PLATES AND SCREWS. ON (B)(6) 2018, THE IRRIGATION AND DRAINAGE OF THE WOUND WAS PERFORMED. HARDWARE WAS NOT REMOVED. SURGEON TREATING PATIENT CONSERVATIVELY AT PRESENT. SURGEON HAS STATED PATIENT IS NON-COMPLIANT DUE TO MENTAL STATUS AND HAS URINATED ON WOUNDS. THE PATIENT RETURNED TO SURGERY AGAIN ON (B)(6) 2018 FOR HARDWARE REMOVAL DUE TO INFECTION. THIS TIME HARDWARE WAS REMOVED IN ITS ENTIRETY/LATERAL AND MEDIAL SIDES. ALL HARDWARE WAS INTACT. PATIENT WAS DEBRIDED AND A NEW 4.5 LOCKING COMPRESSION PLATE (LCP) OF THE PROXIMAL TIBIA WAS INSERTED ON LATERAL SIDE. WOUND VACS WERE APPLIED TO BOTH SIDES. SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 3.5 MM VA-LCP PROX TIBIA PLATE SMALL BEND/12H/207 MM/RIGHT. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Patient problems: Post Operative Wound Infection

    MAUDE report 7435964 ↗

Other PLATE, FIXATION, BONE devices

All PLATE, FIXATION, BONE devices →

Sources and updates

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