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VA-LCP 02.118.404Recalls & reported problems

Synthes GmbH · 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT · Class 2 · Implant

All models of VA-LCP (256)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
8
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982038869), received between Jul 27, 2017 and Sep 7, 2021 — classified as 5 injuries, 3 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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem5
  • Device-Device Incompatibility3
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Code Available2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Discomfort1
  • Impaired Healing1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT, TWO(2) UNKNOWN SCREWS WAS FOUND NOT LOCKING PROPERLY INTO THE 2.7MM VA LATERAL DISTAL FIBULA PLATE. THIS REPORT IS FOR ONE (1) 2.7 VA-LCP LATERAL DSTL FIB PL/5 H/RT. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12433217 ↗
  • InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE AFTER STERILIZATION, IT WAS DISCOVERED THAT THERE WERE DEVICES THAT HAD AN UNKNOWN ALLEGATION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THIRTEEN (13) DEVICES. THIS REPORT IS FOR (1) 2.7 VA-LCP LATERAL DSTL FIB PL/5 H/RT. THIS REPORT IS 7 OF 13 FOR (B)(4).

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 12017971 ↗
  • InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT THE HARDWARE REMOVAL, IRRIGATION AND DEBRIDEMENT DUE TO INFECTION AND COMPLETE FRACTURE UNION. A VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) 5 HOLE DISTAL FIBULA PLATE WAS IMPLANTED 6 MONTHS PRIOR TO TREAT THE DISTAL FIBULA FRACTURE. UPON INCISION THE SURGEON OBSERVED SIGNS OF INFECTION. WHEN THE SURGEON REMOVED THE 6 DISTAL 2.7 VA LOCKING SCREWS, ALL 6 WERE BROKEN OFF AT THE SCREW SHAFT/ HEAD JUNCTION. ONLY THE LOCKING HEADS WERE REMOVED BY THE SCREWDRIVER. THE DOCTOR REMOVED THE SCREWS IN THE SHAFT WITHOUT INCIDENT AND THE PLATE WAS REMOVED. UPON COMPLETION OF THIS, THE SURGEON USED A HEAVY NEEDLE DRIVER TO UNSCREW AND REMOVED ALL 6 BROKEN SCREW SHAFTS WITH MINIMAL ADDITION OF TIME TO THE SURGERY. THE SURGEON DID NOT SUSPECT THAT THE HARDWARE WAS BROKEN PRIOR TO THE REMOVAL SURGERY. PER SURGEON THE FRACTURE WAS WELL HEALED AFTER REMOVING THE PLATE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

    Patient problems: Unspecified Infection

    MAUDE report 11592326 ↗
  • MalfunctionDec 29, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

    IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, THE VARIABLE ANGLE (VA) LOCKING SCREWS DID NOT LOCK INTO THE PLATES USED. AN ALTERNATIVE PLATE WAS USED, AND THE SAME HOLE WAS STRIPPED. LOCKING COMPRESSION PLATE (LCP) DISTAL FIBULA PLATE WAS USED AND IT WORKED. THE DEPTH GAUGE TIP BROKE OFF DURING MEASUREMENT. THE LARGE FRAGMENT PLATE HAD RUST ON IT AS WELL. THE BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THREE (3) MINUTE SURGICAL DELAY. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/3 HOLES/RIGHT (PART NUMBER 02.118.400, LOT UNKNOWN, QUANTITY 1), DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS (PART NUMBER 319.006, LOT UNKNOWN, QUANTITY 1), 4.5MM NARROW LCP® PLATE 11 HOLES/206MM (PART NUMBER 224.611, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11087924 ↗
  • MalfunctionDec 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT ON (B)(6) 2020, THREE (3) 27MM LOCKING SCREWS WOULD NOT LOCK TO THE PLATE. PROCEDURE WAS COMPLETED WITH A FIFTEEN (15) MINUTE DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A 2.7MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) LATERAL DISTAL FIBULA PLATE. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10978961 ↗
  • InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED ON (B)(6) 2019, A PATIENT UNDERWENT REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION LATERAL DISTAL FIBULA PLATE, LOCKING COMPRESSION PLATE HOOK PLATE AND UNKNOWN LOCKING SCREW DUE TO DISCOMFORT. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT WAS FINE. THIS REPORT CAPTURES THE POSTOPERATIVE EVENT OF DISCOMFORT, WHILE THE INTRAOPERATIVE ISSUE OF SCREWDRIVER SHAFT BREAKAGE DURING HARDWARE REMOVAL IS CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Patient problems: Discomfort; No Code Available

    MAUDE report 8479633 ↗
  • InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF ONE (1) VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULA PLATE, ONE (1) LCP LOW BEND MEDIAL DISTAL TIBIA PLATE, FIVE (5) 2.7 VA LOCKING SCREWS, FOUR (4) 3.5 CORTEX SCREWS, ONE (1) 4.0 CANNULATED SCREW, FOUR (4) 2.7 CORTEX SCREWS, AND FIVE (5) VARIABLE ANGLE (VA) LOCKING SCREWS DUE TO PAIN. THE DEVICES WERE ORIGINALLY IMPLANTED ON (B)(6) 2017. ALL IMPLANTS WERE REMOVED SUCCESSFULLY WITH NO ISSUES. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SEVEN DEVICES TOTALING (21). THIS COMPLAINT IS FOR (1) 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE. THIS REPORT IS 1 OF 7 FOR (B)(4).

    Patient problems: Pain

    MAUDE report 7957210 ↗
  • InjuryJul 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A CLOSED ANKLE FRACTURE ON (B)(6) 2016. APPROXIMATELY ONE MONTH AGO, HE WAS SEEN IN THE OFFICE AND A NONUNION WAS NOTED. THE PATIENT HAS NOTED THAT OVER THE PAST COUPLE OF WEEKS HE HAD STARTED DEVELOPING REDNESS TO THE LATERAL ASPECT OF HIS RIGHT ANKLE. HE CONTINUES TO SMOKE HEAVILY. HE HAS BEEN ON ANTIBIOTICS FOR HIS ABDOMINAL INFECTION, HOWEVER HE HAS NOT HAD RESOLUTION OF HIS ANKLE INFECTION. SURGICAL INTERVENTION IS INDICATED. HE IS HERE TODAY FOR HARDWARE REMOVAL OF HIS RIGHT ANKLE (ONE (1) 2.7MM VARIABLE-ANGLE LOCKING COMPRESSION PLATE (VA-LCP) LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT AND EIGHT (8) SCREWS, UNKNOWN QUANTITY OF EACH; 2.7MM VARIABLE-ANGLE (VA) LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, 2.7MM CORTEX SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, 3.5MM CORTEX SCREW SELF-TAPPING 22MM). DORSALIS PEDIS PULSE/POSTERIOR TIBIAL PULSES ARE 2+. THERE IS AN INCISION ON THE LATERAL ASPECT OF THE RIGHT ANKLE THAT IS MOSTLY HE

    Patient problems: Impaired Healing; No Code Available

    MAUDE report 6747041 ↗

Other PLATE, FIXATION, BONE devices

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Sources and updates

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