BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT

    MDR report key: 3242395 · Received July 23, 2013

    Report

    Report Number
    2520274-2013-04557
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 2, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDP
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. DEVICE HISTORY RECORD REVIEW: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    A MATERIALS DEPARTMENT EVALUATION WAS CONDUCTED. THE CHEMICAL COMPOSITION OF THE BROKEN CONDYLAR PLATE TAKEN FROM THE COMPLAINT WAS INVESTIGATED. THE USED MATERIAL CORRESPONDS TO THE DRAWING SPECIFICATION. THE MATERIAL IS 316L.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    MANUFACTURING EVALUATION: PLATE IS BROKEN. NO VISIBLE DAMAGES WHICH ARE IN RELATION WITH THE MANUFACTURING PROCESS. THE RELEVANT DIMENSIONS WERE CHECKED AND NO DEVIATION WAS DETECTED. NO MANUFACTURING RELATED FAULT COULD BE DETECTED. DISPOSITION: INVALID.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THIS IS THE ONLY COMPLAINT FOR THIS PLATE IN THE ENTIRE US COMPLAINT HISTORY. THIS COMPLAINT IS DEEMED INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A 4.5MM VARIABLE ANGLE LOCKING COMPRESSION CURVED CONDYLAR PLATE, SCREWS AND CIRCLAGE WIRE ON AN UNKNOWN DATE FOR A PROXIMAL FEMUR FRACTURE. APPROXIMATELY ONE MONTH POST-OPERATIVELY, IT WAS NOTED ON X-RAY THAT THE PLATE WAS BROKEN, AND AT LEAST ONE OF THE SCREWS WERE BROKEN. PATIENT WAS RETURNED TO OR ON (B)(6) 2103 FOR REVISION. THE BROKEN HARDWARE WAS REMOVED, AND PATIENT WAS REVISED TO A NEW PLATE AND NEW SCREWS WHICH WERE PLACED MORE PROXIMALLY. PREVIOUS SCREWS WERE REMOVED FROM THE FRACTURE AREA. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344214 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/LEFT JDP SYNTHES GMBH 8096599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention