BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI 140*100*40 PEEK

    MDR report key: 12704582 · Received October 27, 2021

    Report

    Report Number
    8030965-2021-09050
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 1, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    GXN
    UDI-DI
    07611819341357
    PMA / PMN Number
    K053199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: PRODUCT CODE: SD800.435; LOT #: 282P640; MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 13 JUL 2021. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE NOT STERILE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, THE PATIENT SPECIFIC IMPLANT (PSI) DID NOT MATCH THE PATIENT'S BONE SHAPE. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING TITANIUM MESH. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) PSI 140 100 40 PEEK. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603994 PSI 140*100*40 PEEK PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE GXN SYNTHES GMBH 282P640 07611819341357

    Patients

    Seq Age Sex Outcome Treatment
    1