BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD800.540 PEEK IMPLANT

    MDR report key: 5027466 · Received August 25, 2015

    Report

    Report Number
    2530088-2015-10567
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    August 12, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    PK053199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. (B)(4) DEVICE 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 (PSI) WAS EXPLANTED ON (B)(6) 2015 DUE TO INFECTION. ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562059 PSI SD800.540 PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE GXN SYNTHES BRANDYWINE 7892318

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention