BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW, PLATE

    MDR report key: 31828 · Received April 5, 1996

    Report

    Report Number
    MW1008816
    Event Type
    Injury
    Date Received
    April 5, 1996
    Date of Event
    November 1, 1995
    Report Date
    April 4, 1996
    Manufacturer
    ACROMED CORP.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR STATED THAT HE BENT TO GET SOMETHING OUT OF THE REFRIGERATOR. HE FELT SOMETHING IN HIS BACK AND HE COULD NOT STRAIGHTEN UP. HE EXPERIENCED SEVERE PAIN THAT LASTED BETWEEN 3 TO 6 WEEKS. HE COULDN'T WALK, TAKE STEPS. HE ALSO EXPERIENCED PAIN GOING TO THE BATHROOM, AND HIS CHILDREN HAD TO PUT ON HIS SHOES. IT TOOK HIM 20 MIN TO GET IN AND OUT OF BED. DR TOOK AN X-RAY AND TOLD HIM THAT ONE OF THE SCREWS WAS BROKEN. THE PAIN CONTINUED AND GOT WORSE. ON 3/12/96 DR REMOVED THE SCREWS. RPTR STATES THAT HE DOESN'T KNOW IF HE HAS ANY PERMANENT DAMAGE, BECAUSE HE IS STILL HEALING FROM THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICLE SCREW, PLATE Implant PEDICLE SCREW, PLATE MCV ACROMED CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability