BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI SD800.430 PEEK IMPLANT

    MDR report key: 3851639 · Received June 5, 2014

    Report

    Report Number
    2530088-2014-10149
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    PK033868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS STILL IMPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR PATIENT SPECIFIC IMPLANT ITEM SD800.430, LOT 7671515, IT WAS DETERMINED THAT THIS IMPLANT WAS PRODUCED TO COMPLY WITH THE DEVICE SPECIFICATIONS, AND WAS PRODUCED FROM THE CORRECT RAW MATERIAL, AS LISTED ON BOTH THE PATIENT SPECIFIC IMPLANT ROUTER / INSPECTION SHEET AND THE BRANDYWINE ROUTING. ALL PACKAGING AND LABELING COMPLIED WITH THE LABELING AND PACKAGING PRESENTATION FORM AS INDICATED ON THE PACKAGING LABEL LOG, THERE WERE NO NON-CONFORMING REPORTS ON THIS LOT NUMBER (PRODUCT LOT NUMBER AND RAW MATERIAL LOT NUMBER). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SPECIFIC IMPLANT DID NOT FIT PROPERLY; THE SURGEON NEEDED TO MODIFY IT EXTENSIVELY. IT WAS REPORTED THAT SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328923 PSI SD800.430 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE GXN SYNTHES BRANDYWINE 7671515

    Patients

    Seq Age Sex Outcome Treatment
    1