BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD800.418 PEEK IMPLANT

    MDR report key: 6124483 · Received November 23, 2016

    Report

    Report Number
    2530088-2016-10327
    Event Type
    Injury
    Date Received
    November 23, 2016
    Report Date
    November 1, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    K053199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS REPORTEDLY NOT BEEN EXPLANTED YET. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. MANUFACTURE DATE: JULY 15, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. DEVICE HISTORY RECORD (DHR) REVIEW FOUND NO RELEVANT ISSUES THAT WOULD RESULT IN THIS PRODUCT COMPLAINT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 WHO WAS IMPLANTED WITH TWO PSI (PATIENT SPECIFIC IMPLANTS) PEEK CRANIAL IMPLANTS ON (B)(6) 2016, DEVELOPED AN INFECTION POSTOPERATIVELY. THE INFECTION SITE WAS CLEANED AND THE PEEK CRANIAL IMPLANTS WERE REMOVED ON AN UNKNOWN DATE. THE INFECTION IS REPORTEDLY GONE. THE PATIENT WILL BE REVISED AND NEW PEEK CRANIAL IMPLANTS WILL BE IMPLANTED. THE SURGERY DATE WILL BE DETERMINED BUT IS ANTICIPATED TO OCCUR BY THE END OF (B)(6) 2016. THIS IS REPORT 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774991 PSI SD800.418 PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE GXN SYNTHES BRANDYWINE H148430

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention