BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L INF-PL SIZ L 0°

    MDR report key: 3030054 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01276
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED AND IT STATES THAT A MANUFACTURING FAULT CAN BE RULED OUT AS THE MANUFACTURING DOCUMENTS WHERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WHERE FOUND. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH PRODISC-L ON (B)(6) 2013, LEVEL L5-S1. PATIENT DID CLINICALLY WELL UNTIL (B)(6) 2013; AN X-RAY SHOWED THE PLOY INLAY EJECTED FROM THE INFERIOR COMPONENT. THE L5 VERBAL BODY APPEARED TO HAVE LYSTHESED FORWARD ON S1. PATIENT WAS REVISED ON (B)(6) 2013. THE POLY WAS REMOVED ALONG WITH BOTH SUPERIOR AND INFERIOR COMPONENTS WITH NO DAMAGE TO THE ENDPLATES. AS ENDPLATE INTEGRITY WAS MAINTAINED, FURTHER PRODISC-L COMPONENTS WERE IMPLANTED WITHOUT INCIDENT. THIS IS 2 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134284 PRODISC-L INF-PL SIZ L 0° MJO SYNTHES GMBH 3343637

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention