BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI SD802.357 PEEK IMPLANT

    MDR report key: 3223326 · Received July 12, 2013

    Report

    Report Number
    2530088-2013-01003
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    K053199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING A PROCEDURE ON (B)(6) 2013, REPORTEDLY THE PATIENT SPECIFIC IMPLANT, PSI DID NOT FIT PROPERLY AND THE POSTERIOR EDGE WAS TOO HIGH. THE IMPLANT HAD TO BE CONTOURED ON THE EDGES AND SIDES WITH A BURR TO CREATE A BETTER FIT, RESULTS SATISFACTORY. THE SURGERY WAS PROLONGED AN ADDITIONAL 15-30 MINUTES. THIS IS 1 OF 2 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324039 PSI SD802.357 PEEK IMPLANT GXN SYNTHES BRANDYWINE 7401830

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR