VA-LCP 02.118.202Recalls & reported problems
Synthes GmbH · 2.7/3.5MM VA-LCP ANTEROLATERAL DISTAL TIBIA PL/4 HOLES/RIGHT · Class 2 · Implant
All models of VA-LCP (256)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982038302), received between Jan 14, 2019 and May 24, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- No Apparent Adverse Event1
Patient problems
- Bone Fracture(s)1
- No Code Available1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 24, 2019No Apparent Adverse Event; No Apparent Adverse Event
THERE WERE SEVEN (7) PLATES AND TWENTY-SIX (26) SCREWS REMOVED. THIS COMPLAINT INVOLVES THIRTY-THREE (33) DEVICES. THIS IS REPORT 1 OF 10 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 1 OF 33 DEVICES. PLEASE SEE THE LINKED COMPLAINTS (B)(4), (B)(4), AND (B)(4) FOR ADDITIONAL DEVICES.
Patient problems: Bone Fracture(s); Nonunion/Delayed-union Bone Fracture
MAUDE report 8640247 ↗InjuryJan 14, 2019Crack; Crack
IT WAS REPORTED THAT A PATIENT HAD INJURY ON OR NEAR (B)(6) 2018 AND UNDERWENT IMPLANT PROCEDURE ON (B)(6) 2018. PATIENT HAD TWO METAL PLATES ATTACHED TO HER TWO LOWER LEG BONES. POST-OPERATIVE, THE PLATE WAS IDENTIFIED TO BE CRACKED ON (B)(6) 2018, VIA X-RAY. ON (B)(6) 2018, PATIENT UNDERWENT REVISION SURGERY DUE TO A CRACKED VARIABLE ANGLE-LOCKING COMPRESSION PLATE ANTEROLATERAL DISTAL TIBIA 4 HOLES/RIGHT. A CRACK HAD DEVELOPED IN ONE OF THE PLATES RUNNING FROM THE SIDE OF ONE OF THOSE HOLES TO THE EDGE OF THE PLATE. THE PLATE WAS REMOVED AND REPLACED WITH A LARGER ONE. THE SECOND SURGERY DELAYED THE PATIENT'S RECOVERY BY FOUR MONTHS. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICE: SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 10). THIS REPORT IS FOR ONE (1) PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 8244912 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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