VA-LCP 02.127.260Recalls & reported problems
Synthes GmbH · 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/14H/237MM/RIGHT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982043665), received between Jun 28, 2017 and Feb 18, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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 Problem1
- Break1
- Corroded1
- Material Twisted/Bent1
Patient problems
- Failure of Implant1
- Foreign Body Reaction1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Corroded
IT WAS REPORTED THE PATIENT PRESENTED WITH A FOREIGN BODY SENSATION POSTOPERATIVELY. DURING THE SUBSEQUENT HARDWARE REMOVAL SURGERY, THE PLATE WAS FOUND TO BE RUSTING.
Patient problems: Foreign Body Reaction
MAUDE report 24380151 ↗InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(4). CLINICAL ADVERSE EVENT RECEIVED FOR POSTOPERATIVE ADVERSE EVENT: OTHER ¿ SKIN BREAKDOWN OVER HARDWARE. DEVICE AND PROCEDURE(RELATEDNESS). DEVICE RELATED: POSSIBLY RELATED. PROCEDURE RELATED: POSSIBLY RELATED. DATE OF EVENT: NOT AVAILABLE, BETWEEN 3 TO 12 MONTHS POSTOP. DATE OF IMPLANT: (B)(6) 2024. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: CT SCAN, RESULTED IN A MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR FUNCTION.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 22777727 ↗MalfunctionApr 5, 2023Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON (B)(6) 2023, THE THREADS STRIPPED ON THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE WAS DISCOVERED DURING PRE-OP SETUP. THIS REPORT INVOLVES ONE 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/14H/237MM/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16681868 ↗InjuryJun 28, 2017Break; Break
IT WAS REPORTED THAT A PATIENT WAS REVISED TO A SUPRAPATELLAR TIBIAL NAIL ON (B)(6) 2017 DUE TO POOR BONE HEALING, NONUNION, AND A BROKEN PLATE. THE PATIENT WAS ORIGINALLY IMPLANTED WITH A LATERAL PROXIMAL TIBIAL PLATE, A MEDIAL PROXIMAL TIBIAL PLATE AND SCREWS ON (B)(6) 2017. THE PATIENT WAS WALKING POSTOPERATIVELY DESPITE BEING INSTRUCTED TO BE NON-WEIGHT BEARING. THE PATIENT SUBSEQUENTLY HAD POOR BONE HEALING AND NONUNION. IT WAS DISCOVERED ON AN UNKNOWN DATE THAT THE LATERAL PLATE WAS BROKEN. THE LATERAL PLATE, SEVEN 3.5 VARIABLE ANGLE LOCKING SCREWS (02.127.1XX) AND FIVE 3.5 CORTEX SCREWS WERE REMOVED INTACT. THE MEDIAL PLATE, FOUR CORTEX SCREWS (204.8XX), AND TWO LOCKING SCREWS (212.1XX) WERE REMOVED; TWO OF THE CORTEX SCREWS WERE BROKEN (ALL PIECES WERE REMOVED). TWO 3.5 CORTEX SCREWS (204.8XX) AND TWO WASHERS (219.98) FROM THE INITIAL SURGERY WERE LEFT IN THE PATIENT. A SUPRAPATELLAR TIBIAL NAIL (04.034.561S) AND SIX 5.0 LOCKING SCREWS WERE IMPLANTED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH POSITIVE PATIENT OUTCOME. THIS COMPLAINT INVOLVES 3 DEVICES. REPORTED CONCOMITANT DEVICES; MEDIAL PROXIMAL TIBIAL PLATE (PART # 239.958, LOT # 6577675, QTY. 1); UNKNOWN 3.5 VARIABLE
Patient problems: Failure of Implant; No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 6673470 ↗
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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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