BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT

    MDR report key: 3971813 · Received July 31, 2014

    Report

    Report Number
    1000562954-2014-10145
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 3, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDP
    PMA / PMN Number
    PK110354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. ADDITIONAL PRODUCT CODES: HRS AND HWC. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE BREAKAGE OCCURRED AT THE FIFTH PROXIMAL COMBINATION PLATE HOLE AT THE THREADED PART IN THE SHAFT AREA OF THE PLATE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, IT CAN BE CONCLUDED THAT THE IMPLANT WAS SUBJECTED TO LOW DYNAMIC BENDING LOADS (ONE SIDED). BECAUSE OF THE NON-CONSOLIDATION THE VARIABLE ANGLE LOCKING COMPRESSION PLATE HAD TO WORK AS A SINGLE STABILIZER OVER A CERTAIN PERIOD OF TIME. CONSTANT ALTERNATING LOAD CYCLES (DURING WALKING) LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE VARIABLE ANGLE LOCKING COMPRESSION PLATE. THE IMPLANT COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF PLAYED A CERTAIN ROLE IN THE COMPLAINT OF THE DEVICE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAD A REVISION PROCEDURE DUE TO A BROKEN PLATE. ON (B)(6) 2014, THE FIRST SURGERY OCCURRED WITH NO PROBLEMS. ON (B)(6) 2014, THE PATIENT FELT A LOT OF PAIN AND IMMEDIATELY WENT TO THE HOSPITAL; THE PHYSICIAN PERFORMED RADIOGRAPHIC STUDIES AND DISPLAYED THE PLATE WAS BROKEN. THE PATIENT DENIES A FALL OR SOME KIND OF EFFORT. ON (B)(6) 2014, THE SECOND SURGERY OCCURRED. IN THE REMOVAL SURGERY THE SURGEON IDENTIFIED THE BROKEN PLATE AND SHOWED THAT THE FRACTURE HAD NOT YET CONSOLIDATED AND PROCEEDED TO PLACE THE NEW PLATE. THE PATIENT WAS REALLY STABLE BEFORE THE SECOND OPERATION THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446692 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT IMPLANT, FIXATION DEVICE, CONDYLAR PLATE JDP SYNTHES MEZZOVICO 8558042

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention