VA-LCP 02.118.207Recalls & reported problems
Synthes GmbH · 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 HOLES/LEFT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982038401), received between Apr 4, 2017 and Jul 16, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Adverse Event Without Identified Device or Use Problem1
- No Apparent Adverse Event1
Patient problems
- Failure of Implant2
- No Code Available2
- Nonunion/Delayed-union Bone Fracture2
- Pain1
- Physical Asymmetry1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS REPORTED THAT AN 8 HOLE ANTEROLATERAL PLATE BROKE IN THE PATIENT POST-OPERATIVELY. PATIENT'S TIBIA LOST REDUCTION OF THE FRACTURE AND A REVISION SURGERY WAS REQUIRED.
Patient problems: Physical Asymmetry
MAUDE report 22518431 ↗InjuryJun 26, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, A PATIENT PRESENTED WITH POSTOPERATIVE NON-UNION AND A BROKEN 2.7/3.5 VA ANTEROLATERAL DISTAL TIBIAL PLATE. THE BROKEN HARDWARE WAS REMOVED AND A REVISION WAS COMPLETED WITH A NEW 2.7/3.5 VA ANTEROLATERAL PLATE AND SUBSEQUENT BONE GRAFTING. THIS REPORT INVOLVES ONE 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/8 HOLES/LEFT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 17197508 ↗InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT AN ANKLE PROCEDURE IN (B)(6) 2018 TO IMPLANT TWO (2) LOCKING COMPRESSION PLATE (LCP) ONE THIRD TUBULAR PLATES, ONE (1) 2.7/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) ANTEROLATERAL DISTAL TIBIA PLATE, ONE (1) 2.7/3.5MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) MEDIAL DISTAL TIBIA PLATE, THIRTEEN (13) 3.5MM CORTEX SCREWS, TWELVE (12) 2.7MM VA LOCKING SCREWS, ONE (1) 7.0MM WASHER, ONE (1) 4.0MM CANNULATED SCREW, AND ONE (1) 4.0MM CANCELLOUS SCREW. PATIENT WAS RETURNED TO SURGERY ON SEPTEMBER 17, 2018 WHERE ALL HARDWARE WAS REMOVED DUE TO INFECTION, INFLAMMATION, AND DELAYED HEALING. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT STATUS REPORTED AS OKAY. PATIENT IS REPORTED TO BE INCARCERATED AND NON-COMPLIANT. THIS REPORT IS FOR ONE (1) 2.7/3.5MM VA LCP ANTEROLATERAL DISTAL TIBIA PLATE. THIS IS REPORT 3 OF 9 FOR (B)(4).
Patient problems: Unspecified Infection
MAUDE report 7944321 ↗InjuryMay 17, 2017Break; Break
IT WAS REPORTED THAT PATIENT WENT THROUGH NON-UNION REPAIR OF TIBIA FIBULA OPEN REDUCTION INTERNAL FIXATION SURGERY ON (B)(6) 2015. POST-OPERATIVE X-RAYS TAKEN ON AN UNKNOWN DATE REVEALED THAT PATIENT HAD DEVELOPED NON-UNION AGAIN AND ONE (1) VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) ANTEROLATERAL DISTAL TIBIA PLATE, ONE (1) 2.7MM VARIABLE ANGLE (VA) LOCKING SCREW, ONE (1) 2.7MM CORTEX SCREW AND FIVE (5) UNKNOWN SCREWS WERE BROKEN. HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2017. NON SYNTHES IMPLANTS WERE ADDED. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT WAS REPORTED AS STABLE. SURGICAL DELAY IS NOT KNOWN. IT IS UNKNOWN IF THE FRAGMENTS WERE GENERATED FROM BROKEN DEVICE AND IF THE BROKEN FRAGMENTS WERE RETAINED IN THE BONE. ALSO, IT IS UNKNOWN IF OTHER MEDICAL INTERVENTION WAS REQUIRED AND IF ANY UNANTICIPATED X-RAYS WERE TAKEN. CONCOMITANT MEDICAL PRODUCTS: 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 5H/LEFT/99MM (PART # 02.112.141, LOT # 6955664, QUANTITY # 1), 3.5MM CORTEX SCREW SELF-TAPPING 14MM (PART # 204.814, LOT # UNKNOWN, QUANTITY # 1), 3.5MM LOCKING SCREW SELF-TAPPING W/STARDRIVE(TM) RECESS 12MM (PART # 212.102, LOT # UNKNOWN, QUANTITY # 2), 3.5MM LOCKING SCREW SELF
Patient problems: Failure of Implant; No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 6572492 ↗InjuryApr 4, 2017Break; Break
IT WAS REPORTED THAT A PATIENT RECEIVED A PLATE AND SCREWS ON AN UNKNOWN DATE AND FELL OFF A LADDER DECORATING FOR CHRISTMAS IN (B)(6) 2016. THE PATIENT EXPERIENCED SOME PAIN AND WENT BACK TO SEE THE DOCTOR. AN X-RAY WAS PERFORMED ON (B)(6) 2017 TO CHECK THE INCISION SITE. X-RAY SHOWED A BROKEN PLATE. THE PATIENT UNDERWENT A REVISION ON (B)(6) 2017 TO REMOVE THE BROKEN PLATE. THE BROKEN PLATE WAS REMOVED WITHOUT ISSUES. THE SCREWS THAT WERE REMOVED WERE ALL INTACT. THE PATIENT WAS REVISED WITH A NEW PLATE AND SCREWS. THERE WAS NO TIME DELAY REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS STABLE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available; Pain
MAUDE report 6458791 ↗
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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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