BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE SYSTEM SCREWS

    MDR report key: 130180 · Received November 3, 1997

    Report

    Report Number
    2916714-1997-00013
    Event Type
    Injury
    Date Received
    November 3, 1997
    Date of Event
    October 21, 1997
    Report Date
    November 3, 1997
    Manufacturer
    AESCULAP/JBS SA
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SALES REP REPORTED THAT A MALE PT UNDERWENT SURGERY ON 10/29/97 TO EXPLANT 2 SPINE SYSTEM SCREWS (CATALOG #SW830T) WHICH HAD FRACTURED. THE SPINE SYSTEM HARDWARE WAS INITIALLY IMPLANTED IN 5/97. THE FRACTURED SCREWS, LOCATED AT L5-S1, WERE NOTED ON A RECENT X-RAY. THE PT HAD NO COMPLICATIONS AFTER THE EXPLANT SURGERY. THE SURGEON NOTED THAT THE DESIRED FUSION HAD BEEN ACHIEVED. THE SCREWS ARE BEING RETURNED TO THE MFR FOR EVAL. THE MALFUNCTION IS OCCURRING BELOW THE FREQUENCY AND SEVERITY THAT ARE USUAL FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE SYSTEM SCREWS Implant BONE SCREW JDN AESCULAP/JBS SA * LT110KG21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other| R