BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT

    MDR report key: 2993825 · Received March 8, 2013

    Report

    Report Number
    8030965-2013-00797
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDP
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PLATE IS BROKEN APART AT THE LOCKING HOLE OF THE HOLE VA-2 AND HAS A CRACK AT THE HOLE VA-3. ALL FEATURES THAT COULD BE MEASURED PASSED SPECIFICATIONS. SOME FEATURES COULD NOT BE MEASURED DUE TO DAMAGE. THE FRACTURE FACE IS HOMOGENOUS, WHICH INDICATES MATERIAL CONFORMITY. BASED ON THE APPEARANCE OF THE BREAKAGE AND AS THE PLATE HAS ALSO A CRACK ON ONE SIDE BELOW THE FRACTURE WE CAN ONLY ASSUME THAT THE PLATE WAS EXPOSED TO TOO HIGH DYNAMIC BENDING LOADS DURING USE, WHICH CAN LEAD TO A MATERIAL FATIGUE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: HRS, HWC. REPORTED DATE OF IMPLANT WAS (B)(6) 2012, DATE UNKNOWN. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ORIGINAL FIRST IMPLANTATION OF THE PLATE WAS PERFORMED IN MEXICO, DATE UNKNOWN. A REVISION SURGERY WAS PERFORMED IN (B)(6) 2012. PATIENT WAS IMPLANTED WITH 4.5MM VA-LCP CURVED CONDYLAR PLATE AND SCREW CONSTRUCT IN (B)(6) 2012. REPORTEDLY THE PATIENT COMPLAINED OF PAIN AND IT WAS DISCOVERED THAT THERE WAS A NON-UNION. THE PLATE BROKE POST-OPERATIVELY. THE PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 FOR REVISION SURGERY. PATIENT WAS REPLATED WITH NEW HARDWARE. THE REVISION ORIF OF FEMUR WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98879 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT JDP SYNTHES GMBH 7567035

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention