BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C SIZ LD H6

    MDR report key: 3033566 · Received April 3, 2013

    Report

    Report Number
    8030965-2013-01347
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 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

    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 COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.ADDITIONAL INFORMATION.A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. SINCE NO MATERIAL WAS RETURNED FOR ANALYSIS THE PRESENT COMPLAINT CAN NOT BE FULLY ANALYZED AND WE ARE NOT ABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: REVISION OF PRODISC C DUE TO NECK PAIN. PRODISC C, SIZE LD, HEIGHT 6MM, INITIALLY IMPLANTED (B)(6) 2010 IN DISC SPACE C5,C6. REVISION SURGERY DUE TO PERSISTING NECK PAIN. SURGEON STATED THAT X-RAYS SHOWED SLIGHTLY ROTATED PRODISC C ENDPLATES, RELATIVE TO EACH OTHER. HE ALSO STATED THAT THE CERVICAL SPINE WAS PROBABLY SLIGHTLY ROTATED DURING INITIAL IMPLANTATION. THE REVISION SURGERY WENT WELL. PATIENT RECEIVED AN ILIAC CREST AUTOGRAFT WITH A 20MM CSLP PLATE AND LENGTH 16MM, 4.5MM SCREWS. SURGEON NOTED THAT PATIENT HAS VERY GOOD BONE QUALITY AND THE PRODISC C WAS PROBABLY WRONGLY IMPLANTED AND THE REVISION SURGERY WAS NOT IMPLANT RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136484 PRODISC-C SIZ LD H6 MJO SYNTHES GMBH 2006002001

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention