VA-LCP 02.118.402Recalls & reported problems
Synthes GmbH · 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/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
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982038821), received between Feb 6, 2018 and Jul 28, 2025 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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
- Device-Device Incompatibility3
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Device Operational Issue1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
- Bone Fracture(s)1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS RUST ON THE TAMPS / GUIDE BLOCK. IT COULD NOT BE REMOVED. THE LOCKING HOLES ON THE PLATES WERE STRIPPED. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22630108 ↗InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT HAD A RIGHT ANKLE SURGERY 3 MONTHS PRIOR TO RETURNING TO ER WITH NEW, BILATERAL ANKLE FRACTURES. ALL HARDWARE WERE STILL INTACT. PATIENT RE-FRACTURED ANKLE IN DIFFERENT PLACES AND ALSO THE OTHER ANKLE FROM NEW INJURY. HARDWARE REMOVAL SURGERY WAS SCHEDULED FOR (B)(6) 2022. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 14960114 ↗MalfunctionJan 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2020, THE VA-LCP LATERAL DISTAL FIBULA PLATE WAS UNABLE TO BE SECURED WITH THE UNKNOWN LOCKING SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER PLATE. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREW: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11216673 ↗MalfunctionJan 7, 2021Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE VARIABLE ANGLE LOCKING PLATE HOLE DIDN¿T WORK. MULTIPLE SCREWS TRIED, VARIABLE ANGLE DRILL GUIDE USED, PROPER TECHNIQUE APPLIED. PLATE HAD TO BE REMOVED AND NEW LCP PLATE PUT IN INSTEAD. THERE WAS SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES REPORTED. CONCOMITANT DEVICES REPORTED: SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), VARIABLE ANGLE DRILL GUIDE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11135935 ↗MalfunctionMay 22, 2019Device-Device Incompatibility; Device-Device Incompatibility
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF ANKLE. DURING THE PROCEDURE, THE SURGEON ATTEMPTED, WHILE USING PROPER TECHNIQUE, TO USE VARIABLE ANGLE LOCKING SCREWS IN THE DISTAL PORTION OF THE VARIABLE ANGLE LOCKING COMPRESSION LATERAL DISTAL FIBULA PLATE, AND THEY WOULD NOT LOCK INTO PLACE. TWO (2) DIFFERENT SCREWS WERE USED AT DIFFERENT ANGLES, BUT STILL UNSUCCESSFUL. THERE WAS A SURGICAL DELAY OF AN UNKNOWN AMOUNT OF MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NON-LOCKING SCREW. THE PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 2.7 MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/RIGHT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8632272 ↗MalfunctionFeb 7, 2018Break; Break
IT WAS REPORTED THAT DURING INITIAL OPEN REDUCTION OF INTERNAL FIXATION ANKLE PROCEDURE ON (B)(6) 2018, UNKNOWN QUANTITY OF UNKNOWN 2.7 MM VA LOCKING SCREWS WERE NOT LOCKING IN FEW OF THE DISTAL HOLES IN DISTAL FIBULAR PLATE. THESE HOLES IN THE PLATE WERE KEPT EMPTY AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. THIS COMPLAINT INVOLVES ONE DEVICES THIS REPORT IS 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7250005 ↗MalfunctionFeb 6, 2018Device Operational Issue; Device Operational Issue
IT WAS REPORTED THAT DURING INITIAL OPEN REDUCTION OF INTERNAL FIXATION ANKLE PROCEDURE ON (B)(6) 2018, UNKNOWN QUANTITY OF UNKNOWN 2.7 MM VA LOCKING SCREWS WERE NOT LOCKING IN FEW OF THE DISTAL HOLES IN DISTAL FIBULAR PLATE. THESE HOLES IN THE PLATE WERE KEPT EMPTY AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. THIS COMPLAINT INVOLVES ONE DEVICE. (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7246775 ↗
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- 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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