BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW SD 3.5X12MM

    MDR report key: 3061597 · Received April 11, 2013

    Report

    Report Number
    3004608878-2013-00062
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 11, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    ODP
    PMA / PMN Number
    K102323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SECOND 3.5X12MM SCREW STRIPPED DURING AN ANTERIOR CERVICAL DISK FUSION SURGERY AND THE SURGEON WAS UNABLE TO REMOVE IT FROM THE IMPLANT SO THE SURGEON TOOK OUT THE OTHER SCREWS AND THE IMPLANT. THE DISTRIBUTOR SAID HE WAS UNCERTAIN IF THE ISSUE WAS FROM THE SCREW OR FROM THE PATIENT'S BONE QUALITY. THIS ADDED 10-15 MINUTES TO THE SURGERY TIME. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155432 SCREW SD 3.5X12MM CERVICAL CAGE PLATE ODP INTEGRA LIFESCIENCES CORPORATION W17927

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 27134013 SCREW ST 4X13MM| 27101808 IMPLANT: 18X15X8MM 6 DEG