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
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 ↗
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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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