VA-LCP 02.118.208SRecalls & reported problems
Synthes GmbH · 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/10 H/RT-STER · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982038432), received between Dec 20, 2017 and Dec 20, 2017 — classified as 1 injury.
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.
Most reported problems
Device problems
- Break1
Patient problems
- Failure of Implant1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2017Break; Break
IT WAS REPORTED THAT A HARDWARE REMOVAL AND REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) WAS PERFORMED ON (B)(6) 2017 DUE TO TIBIA NON-UNION AND A BROKEN PLATE. THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2017. SUBSEQUENTLY IT WAS DISCOVERED THAT THE PLATE HAD BROKEN AND THERE WAS A FRACTURE NON-UNION. IT IS NOTED THAT THE PATIENT IS (B)(6), AND WAS LIKELY NON-COMPLAINT WITH POST-OPERATIVE NON-WEIGHT BEARING INSTRUCTIONS. REMOVED HARDWARE INCLUDED: ONE BROKEN PLATE AND TEN SCREWS. ALL HARDWARE WAS REMOVED INTACT EXCEPT FOR ONE 2.7MM LOCKING SCREW, WHICH BROKE AT THE HEAD DURING REMOVAL. AS THE SURGEON WENT TO REMOVE THE SCREW, THE HEAD SNAPPED OFF. THE SCREW SHAFT FRAGMENT WAS LEFT IN THE PATIENT¿S BONE. THE PATIENT WAS REVISED TO ANOTHER PLATE AND SCREWS WITH AUTOGRAFT AND ALLOGRAFT BONE. THERE WAS NO REPORTED SURGICAL DELAY, NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT PARTS REPORTED: 2.7 MM LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), 2.7 MM VA LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 5), 3.5 MM LOCKING SCREWS (PART # UNKNOWN, LOT # UNKN
Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture
MAUDE report 7134676 ↗
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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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