BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE CONDYLAR

    MDR report key: 2924638 · Received January 22, 2013

    Report

    Report Number
    2520274-2013-00532
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 28, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND 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.

    Description of Event or Problem · 1

    ORIF COMMINUTED DISTAL FEMORAL FRACTURE EVENT: SURGEON WAS USING A LONG 4.5MM VA-LCP CURVED CONDYLAR PLATE IN A BRIDGE PLATING TECHNIQUE TO EXTEND TO THE GREATER TROCHANTER FOR THE LARGE AREA ADJACENT TO THE FRACTURE. SURGEON DID THE FINAL TIGHTENING OF THE VA SCREWS, BUT DID NOT LIKE THE REDUCTION; SURGEON REMOVED THE DISTAL SCREWS, REPOSITIONED THE PLATE AND RE IMPLANTED NEW DISTAL SCREWS; SURGEON WAS THEN SATISFIED WITH THE REDUCTION. AT A 3 WEEK POST OP VISIT, X-RAYS SHOWED 3 OF THE 4 DISTAL LOCKING SCREWS WERE BACKING OUT .EVEN THOUGH PATIENT SHOWS SIGNS OF HEALING, THE FEMUR SEEMS SLIGHTLY MALALIGNED. NO REVISION HAS BEEN SCHEDULED AT THIS TIME. PRIOR TO THE FRACTURE, PATIENT HAD BEEN CANDIDATE FOR TOTAL KNEE REPLACEMENT. NOW KNEE REPLACEMENT WILL NOT TAKE PLACE UNTIL MORE HEALING OF THE FRACTURE OCCURS. MALALIGNMENT WILL BE TREATED AT THE TIME THE TOTAL KNEE REPLACEMENT IS DONE. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30065 PLATE CONDYLAR HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE, SCREWS