BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-L SUP-PL SIZ L 6°

    MDR report key: 2896294 · Received January 4, 2013

    Report

    Report Number
    2520274-2013-00052
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    June 15, 2009
    Report Date
    June 19, 2009
    Manufacturer
    SYNTHES
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. ACTUAL IMPLANT DATE NOT KNOWN. ACTUAL EXPLANT DATE NOT KNOWN. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED. PLACEHOLDER.

    Description of Event or Problem · 1

    EU COMPLAINT HANDLING UNIT REPORTED A PRODISC-L SUPERIOR PLATES AND INLAY REVISION. THE OPERATION TOOK PLACE AT (B)(4) SPINE CENTER IN (B)(6) 2006, USING A PRODISC-L, LEVELS L5-S1 AND L4-L5. THE INLAY L5-S1 LUXATED IN (B)(6) 2007, WITHOUT ANY TRAUMA INVOLVED. A REVISION SURGERY WAS PERFORMED IN (B)(6) SPINE CENTER IN (B)(6) 2007. THE LUXATED INLAY WAS REMOVED AND A NEW ONE WAS INSERTED. THE NEW INLAY LUXATED ONE WEEK LATER, IT WAS TOUCHING THE VENA ILIACA COMMUNIS. IN (B)(6) 2007, THE LEVEL L5-S1 WAS FUSED WITH A POSTERIOR FIXATION CLICK X, IN (B)(6). THE PATIENT SUFFERED FROM RETROGRADE EJACULATION, AND HAD SYMPATICUS DAMAGE. HE LOST HIS TOP LEVEL JOB IN AN INSURANCE COMPANY AND IS NOW MORE OR LESS AN INVALID BECAUSE OF SEVERE PAIN. HE HAD REGULAR PAIN TREATMENT WITH INJECTIONS ONCE A WEEK WITHOUT VERY MUCH HELP. HE HAS TO PAY OUT OF HIS OWN POCKET. ANY LEGAL ISSUES WILL TAKE PLACE IN (B)(6) AS HE WAS OPERATED THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4721 PRODISC-L SUP-PL SIZ L 6° PRODISC-L SUP-PL SIZ L 6° MJO SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention