BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONGER CABLE SYSTEM (SURGICRAFT)

    MDR report key: 328871 · Received April 24, 2001

    Report

    Report Number
    1833824-2001-00004
    Event Type
    Injury
    Date Received
    April 24, 2001
    Report Date
    April 23, 2001
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE DISTRIBUTOR REPORTED TO CO THAT ONE ACCOUNT HAD REPORTED TO THEM THAT ONE PT HAD C-1 AND C-2 SPINAL CABLES BREAK 6 WEEKS POST-OPERATIVELY LATE IN THE YEAR 2000. THIS WAS REPORTED TO CO VIA E-MAIL ON 3/22/2001. IT WAS REPORTED THAT THE CABLES WERE REMOVED. THE CABLES WERE RETURNED FOR EVALUATION. THE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT SHALL ADDRESS THE DEVICE EVALUATION AS SOON AS IT IS COMPLETE. THE CABLES WERE REPLACED WITH THAT OF ANOTHER BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18642 SONGER CABLE SYSTEM (SURGICRAFT) SPINAL CABLE FIXATION JDQ PIONEER SURGICAL TECHNOLOGY 400-695 502364

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R