BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S4 MONOAXIAL SCREW 8.0X45MM

    MDR report key: 680873 · Received February 23, 2006

    Report

    Report Number
    2916714-2006-00003
    Event Type
    Malfunction
    Date Received
    February 23, 2006
    Date of Event
    January 10, 2006
    Report Date
    February 22, 2006
    Manufacturer
    AESCULAP, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGERI BELIEVED TO BE AN L5-S1 SPONDYLOISHESIS REDUCTION AND FUSION. SURGEON HAD DIFFICULTY APPLYING TORQUE TO THE SET SCREWS. THIS WAS A CASE USING JIGS. TABS HAD BEEN REMOVED BEFORE SET SCREW WAS APPLIED. SURGERY PROLONGED 45 MINUTES. SEVERAL ATTEMPTS HAVE BEEN MADE TO CONFIRM DATE (01/20006) OF SURGERY, TYPE (L5-S1) SPONDYLOISHESIS REDUCTION AND FUSION). AND OBTAIN INFORMATION ON STATUS OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S4 MONOAXIAL SCREW 8.0X45MM APPLIANCE, FIXATION, SPINAL, INTERLAMINAL KWP AESCULAP, INC. NA 51229695

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN