BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI SD800.441 PEEK IMPLANT

    MDR report key: 3965017 · Received July 29, 2014

    Report

    Report Number
    2530088-2014-10194
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    PK033868
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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. 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

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR PSI ITEM (B)(4), LOT #7681870, 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 PSI ROUTER / INSPECTION SHEET (F-S315) AND THE BRANDYWINE ROUTING. ALL PACKAGING AND LABELING COMPLIED WITH THE LABELING AND PACKAGING PRESENTATION FORM (LPPF), AS INDICATED ON THE PACKAGING LABEL LOG (F-S252), THERE WERE NO NON-CONFORMING REPORTS (NCR) ON THIS LOT NUMBER. {NO NCR'S ASSOCIATED WITH THE RAW MATERIAL LOT NUMBER (7556237).} 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 CUSTOM POLYETHERETHERKETONE (PEEK) IMPLANT WAS NOT THE CORRECT SIZE. THE SURGEON WAS PERFORMING A CRANIOPLASTY PROCEDURE AND IT WAS DISCOVERED THAT THE IMPLANT WAS THE INCORRECT SIZE. THE SURGEON CUT THE PLATE TO THE CORRECT SIZE. THERE WERE NO REPORTS OF A SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441123 PSI SD800.441 PEEK IMPLANT PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE GXN SYNTHES BRANDYWINE 7681870

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR