BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD800.441 PEEK IMPLANT

    MDR report key: 3871516 · Received June 13, 2014

    Report

    Report Number
    2530088-2014-10160
    Event Type
    Injury
    Date Received
    June 13, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    GXN
    PMA / PMN Number
    PK033868
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. UPON REVIEW OF THE DEVICE HISTORY RECORD FOR PATIENT SPECIFIC IMPLANT ITEM SD800.441, LOT 7569991, 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 (B)(4). 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. THERE WERE ALSO NO NON-CONFORMING REPORTS FOR THIS 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

    THIS REPORT IS AGAINST (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT REPORTEDLY RECOVERED WELL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350161 PSI SD800.441 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE GXN SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention