VA-LCP 02.127.210Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982043467), received between Nov 19, 2018 and Apr 17, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AROUND (B)(6) 2020 THE PATIENT FELL FROM A SCAFFOLDING AND INJURED HIS RIGHT KNEE. THE CT SCAN REVEALED A COMMINUTED BICONDYLAR TIBIAL PLATEAU FRACTURE. AROUND (B)(6) 2020 THE PATIENT UNDERWENT RIGHT TIBIAL ORIF WITH MEDIAL POSTEROMEDIAL PLATING, MEDIAL AND LATERAL MENISCAL REPAIR AND A PROPHYLACTIC 4 COMPARTMENT FASCIOTOMY. THE SURGEON IMPLANTED A PROXIMAL ANTEROLATERAL SYNTHES TIBIAL PLATEAU LOCKING PLATE AND ONE 3.5 POSTEROMEDIAL TIBIAL T PLATE WITH ASSOCIATED SCREWS. THE SURGEON ALSO UTILIZED A SINGLE-USE DRILL BIT. FOLLOWING THE SURGERY OF(B)(6) 2020 THE PATIENT PERFORMED REHABILITATION AND THERAPY AS RECOMMENDED BY HIS MEDICAL PROVIDERS. HOWEVER, HE CONTINUED TO EXPERIENCE PAIN, DISCOMFORT, AND FUNCTIONAL LIMITATIONS IN HIS RIGHT KNEE. ALSO HE EXPERIENCED PROBLEMS WITH WOUND HEALING, INCLUDING INCREASED PAIN, SWELLING, AND DRAINAGE FROM THE INCISION SITE. AROUND (B)(6) 2020 THE PATIENT DIAGNOSED WITH SEPTIC ARTHRITIS. IT WAS DETERMINED THAT THE PATIENT WOULD UNDERGO ADDITIONAL SURGERY FOR HIS WOUND COMPLICATIONS, INCLUDING ARTHROSCOPIC IRRIGATION AND DEBRIDEMENT OF HIS MEDIAL AND LATERAL INCISIONS ALONG WITH THE REMOVAL OF ALL HIS HARDWARE AND THE INSTALL

  Patient problems: Discomfort; Impaired Healing; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16753703 ↗
• MalfunctionApr 10, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2023, DR. REMOVED A SYNTHESE EX FIX FROM A LEG, AND A ORIF OF A TIBIAL PLATEAU WAS PERFORMED. THE SURGEON COMMENTED THAT THE PLATE DID NOT FIT THE PATIENT'S ANATOMY WELL. THE SURGERY PROCEEDED AND WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 3.5 VA PROX TIB PL SMALL BEND/4H/87/RT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710055 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS REMOVAL OF HARDWARE DUE TO MALUNION. A PREVIOUS SURGERY WAS DONE IN MEXICO, AND PATIENTS TIBIA HEALED IN EXTREME VARUS. A CORRECTION SURGERY WAS COMPLETED FOLLOWING THE HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL WAS DUE TO EXTREME VARUS DEFORMITY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 3.5 VA PROX TIB PL SMALL BEND/4H/87/RT THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Deformity/ Disfigurement; Malunion of Bone

  MAUDE report 16248385 ↗
• MalfunctionNov 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) RIGHT LATERAL TIBIA PLATEAU FRACTURE. DURING THE PROCEDURE, THE CANNULATED INTERLOCKING BOLT WOULD NOT THREAD INTO THE PERCUTANEOUS AIMING ARM HOLE OF A LATERAL PROXIMAL TIBIA PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A FIVE (5) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN NUT (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1); UNKNOWN INSERTION HANDLE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/4H/87MM/RIGHT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10772383 ↗
• InjuryNov 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(4) 2018, ONE (1) VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE SMALL BEND WAS MISSING FROM A SET DURING AN UNKNOWN PROCEDURE. IT WAS MENTIONED THAT THE BILL OF THE MATERIALS SHOWED THAT THE PLATE WAS IN THE SET. THE SURGEON ENDED UP USING A SIX (6) HOLE RIGHT PLATE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT HARM/CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8086184 ↗