BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01473

    MDR report key: 3003106 · Received March 13, 2013

    Report

    Report Number
    2520274-2013-01473
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 20, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. IMPLANT DATE IS REPORTED AS FOUR TO SIX WEEKS PRIOR TO (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODES: JDP, HWC. DETERMINED FROM PART NUMBER RECEIVED.

    Description of Event or Problem · 1

    PATIENT INITIALLY INJURED IN A MOTOR VEHICLE ACCIDENT IN (B)(6) 2012. PATIENT WAS REVISED ON (B)(6) 2013.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A VARIABLE ANGLE LOCKING CONDYLAR PLATE WITH LOCKING SCREWS APPROXIMATELY FOUR TO SIX WEEKS AGO FOR A DISTAL FEMORAL FRACTURE. ON (B)(6) 2013, X-RAYS SHOWED THAT AN UNKNOWN NUMBER OF SCREWS HAD BACKED OUT. IT IS REPORTED THAT SURGEON WILL REVISE PATIENT IN THE NEAR FUTURE. THIS REPORT IS FOR AN UNKNOWN CONDYLAR PLATE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105883 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention