VA-LCP 02.127.231Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982043566), received between Dec 27, 2016 and Nov 11, 2021 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SALES CONSULTANT WAS NOTIFIED OF AN ADD ON CASE. THE PATIENT HAD A COMPLAINT TO BE SEEN AFTER A TIBIA PLATEAU FRACTURE AND REPAIR DUE TO SEVERE PAIN AND OTHER COMPLICATIONS. THE ORIGINAL SURGERY TOOK PLACE ON APRIL 2 OF 2021 AND THE PATIENT HAD A DRAINING FISTULA AT THE INCISION SITE AS WELL AS IMPROPER REDUCTION OF THE ORIGINAL FRACTURE. THE SURGEON DECIDED TO REMOVE ALL CURRENT HARDWARE AND VERIFY THE PRESENCE OR THE LACK OF PATHOGENS. ALSO THE PATIENTS HEALTH NEEDS TO BE STABLE BEFORE HE CAN PROCEED WITH A REVISION SURGERY, TO PROPERLY REDUCE THE JOINT LINE AND MAKE THE LIMB USEABLE AGAIN FOR THE PATIENT. THIS REPORT IS FOR ONE (1) 3.5 VA PROX TIB PL SMALL BEND/8H/147/LFT. THIS IS REPORT 1 OF 18 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12796486 ↗
• InjuryNov 9, 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 A PROCEDURE TO TREAT THE DISTAL TIBIA AND FIBULA FRACTURE WITH A TIBIA NAIL AND FIBULA PLATE. THE PATIENT HAD ZERO HEALING PROPERTIES AND CONSEQUENTLY, THE PATIENTS DISTAL LEG WAS QUITE ROTTING OFF. ON (B)(6) 2021 THE TIBIA NAIL ALONG WITH FIVE (5) 5.0MM LOCKING SCREWS WERE REMOVED AND PATIENT'S LEG WAS AMPUTATED BELOW THE KNEE. CLINICAL OUTCOME EXPERIENCED BY THE PATIENT WAS INFECTION. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND/8H/147MM/LEFT. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis; Unspecified Infection

  MAUDE report 12779371 ↗
• 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 DUE TO THE BONE BEING HEALED AND TO AVOID INFECTION. SCREWS REMOVED WERE FIVE (5) UNKNOWN 3.5 VARIABLE ANGLE (VA) LOCKING SCREWS, SIX (6) UNKNOWN 3.5 CORTEX SCREWS, FOUR (4) UNKNOWN 2. 4 CORTEX SCREWS, 1 (ONE) 3.5 VA-LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE AND ONE (1) 2.4 LCP PLATE 4 HOLES. ALL HARDWARE SUCCESSFULLY REMOVED WITH NO ISSUES. ORIGINAL IMPLANT WAS ON APRIL 30,2018. THERE WERE NO KNOWN COMORBIDITIES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (5) REPORTS TOTALING SEVENTEEN (17) DEVICES. THIS COMPLAINT IS FOR (1) 3.5MM VA-LCP PROX TIBIA PLATE SMALL BEND. THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7957936 ↗
• InjuryJun 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A LEFT PROXIMAL TIBIA FRACTURE. PATIENT WAS ORIGINALLY IMPLANTED WITH ONE (1) 3.5 MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATE AND TEN (10) VARIABLE ANGLE LOCKING SCREWS. POST-OPERATIVE, ON AN UNKNOWN DATE, PATIENT PRESENTED WITH AN INFECTION. ON (B)(6) 2017, SURGEON REMOVED ALL IMPLANTS AND REVISED THE PATIENT TO A COMPETITOR¿S DEVICE. IT WAS REPORTED THAT NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. SURGEON PERFORMED A DEBRIDEMENT PROCEDURE AT THE WOUND SITE. IT WAS ALSO REPORTED THAT THE SURGEON FOUND A TIP OF A PENCIL IMBEDDED IN THE SKIN AT THE WOUND SITE. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. THIS IS REPORT 1 OF 11 FOR COM-(B)(4).

  Patient problems: Intraocular Infection

  MAUDE report 6623249 ↗
• InjuryJan 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED PATIENT WAS IMPLANTED WITH TWO (2) 3.5 LOCKING COMPRESSION PLATE (LCP) PROXIMAL TIBIA PLATES, NINE (9) LOCKING SCREWS, AND THREE (3) CORTICAL SCREWS ON (B)(6) 2016 TO REPAIR A LEFT TIBIA PLATEAU FRACTURE. ON UNKNOWN DATE, PATIENT PRESENTED WITH INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2017 WHERE SURGEON REMOVED ALL HARDWARE. PATIENT FRACTURE WAS SUFFICIENTLY HEALED, NO ADDITIONAL HARDWARE WAS IMPLANTED. WOUND WAS CLEANED, DEBRIDED, AND ANTIBIOTIC BEADS WERE APPLIED. ALL EXPLANTED HARDWARE WAS INTACT. AN ADDITIONAL X-RAY WAS TAKEN POST-OPERATIVELY TO VERIFY NO HARDWARE REMAINED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 6263823 ↗
• InjuryDec 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY OCCURRED ON (B)(6) 2016 DUE TO BACKING OUT OF SCREWS AND THE PROXIMAL LOCKING SCREWS WOULD NOT ENGAGE. THE PATIENT HAD BILATERAL PROXIMAL TIBIA AND FEMUR FRACTURES TREATED ON (B)(6) 2016. PATIENT ALSO HAD A PREVIOUS LEFT UNKNOWN TIBIAL NAIL IMPLANTED ON AN UNKNOWN DATE. ON (B)(6) 2016 THE EXFIXES WERE REMOVED AND PATIENT HAD BILATERAL OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PROXIMAL TIBIAS AND RETROGRADE LEFT FEMUR. THE PATIENT RETURNED TO SURGERY ON (B)(6) 2016 FOR IRRIGATION AND DEBRIDEMENT OF THE LEFT TIBIA WITH REMOVAL OF HARDWARE. CLINICAL FINDINGS INCLUDED INFECTION AND INFLAMMATION AND AN ANTIBIOTIC CEMENT SPACER WAS PLACED. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAYS AND NO HARM TO THE PATIENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. CONCOMITANT DEVICE REPORTED: TIBIAL NAIL (QUANTITY 1), EXTERNAL FIXATORS. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6205083 ↗