BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD800.411

    MDR report key: 3738169 · Received April 10, 2014

    Report

    Report Number
    2530088-2014-10053
    Event Type
    Injury
    Date Received
    April 10, 2014
    Report Date
    March 21, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    PK033868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PT WEIGHT: WEIGHT REPORTED AS (B)(6). DATE OF EVENT: UNKNOWN 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.

    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. 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 THERE WAS A REVISION CRANIOPLASTY AND PEEK IMPLANT REMOVAL ON (B)(6), 2014 DUE TO PATIENT PAIN. THE PATIENT HAD THREE PEEK IMPLANTS INSERTED ON A CRANIOPLASTY PROCEDURE ON (B)(6), 2013. THE PATIENT CAME IN APPROXIMATELY SIX TO EIGHT WEEKS AGO COMPLAINING OF PAIN FROM THE RIGHT-SIDE IMPLANT. THE SURGEON TOOK A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND DID NOT SEE ANYTHING WRONG WITH THE IMPLANTS, BUT DECIDED TO TAKE ALL THE IMPLANTS, PLATES, AND SCREWS OUT TO SEE IF IT WOULD ALLEVIATE THE PAIN ISSUE. THE EXPLANT PROCEDURE WAS COMPLETE SUCCESSFULLY AND IT WAS NOTED THAT THE FIXATION OF THE IMPLANTS SEEMED STABLE AND SURGEON REMOVED DEVICES EASILY. THE PATIENT IS DOING WELL. THERE WAS NO DELAY IN SURGERY TIME. THIS IS REPORT 3 OF 16 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217438 PSI SD800.411 PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE GXN SYNTHES BRANDYWINE 7410340

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention