BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS INTERVERTEBRAL DISC

    MDR report key: 3822037 · Received May 20, 2014

    Report

    Report Number
    2530088-2014-10129
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    PP070001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR A PRO-DISC C PART AND LOT NUMBER UNKNOWN WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    THE CUSTOMER SERVICE DEPARTMENT RECEIVED A CALL FROM A PATIENT. THE PATIENT REPORTED THAT SHE UNDERWENT A TRAUMA FUSION PROCEDURE FROM C5-T1 WITH A COMPETITOR'S PRODUCT ON (B)(6) 2011. SHE VISITED A DIFFERENT SURGEON ON AN UNKNOWN DATE THE SURGEON ADVISED HER THAT IMPLANTING A PRODISC-C AT THE ADJACENT LEVEL WOULD HELP HER ALIGNMENT. ON (B)(6) 2011, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF ALL OF THE HARDWARE FROM C5-T1. THE PATIENT WAS THEN IMPLANTED WITH THE PRODISC-C AT C4-5. SINCE THE PROCEDURE, THE PATIENT HAS VISITED OTHER DOCTORS ON UNKNOWN DATES FOR X-RAYS AND HAS BEEN ADVISED THERE IS A MALPOSITION OF THE DEVICE, THE DEVICE IS REPORTED BY THE PATIENT TO BE TILTED DOWN AND POINTING FORWARD . THE PATIENT REPORTED SHE IS IN CONTINUOUS PAIN, CANNOT FLEX, HAS LIMITED RANGE OF MOTION AND HAS KYPHOSIS FROM THE POSITION OF THE DEVICE. THE PATIENT STATES THAT THE SURGEON REPORTED ON HER MEDICAL RECORDS THAT HE IMPLANTED THE PRODISC-C DEVICE DUE TO RADICULOPATHY BUT SHE STATES THIS IS INCORRECT, THAT SHE DID NOT SUFFER FROM THIS. THIS REPORT IS FOR ONE PRO-DISC C PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300448 PROSTHESIS INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention