BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASPER PLATE AND SCREWS FOR ANT. CERVICAL FUSION

    MDR report key: 15340 · Received January 10, 1994

    Report

    Report Number
    2916714-1993-00081
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    September 29, 1993
    Report Date
    November 5, 1993
    Manufacturer
    AESCULAP, AAG
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 3/31/93, THE PT UNDERWENT AN ANTERIOR CERVICAL FUSION WITH CASPER TITANIUM ACF SYSTEM FOR C/5-6 HNP. FOLLOW-UP WITH CERVICAL SPINE FILMS ON 4/23/93 WERE 'NORMAL'. FILMS DONE 5/23/93 DEMONSTRATED A FRACTURED SCREW, PT BEGAN COMPLAINTS OF RECURRING PAIN. ADDITIONAL (REPEAT) PLAN FILMS AND MYELOGRAM WERE PERFORMED. A RE-OPERATION FOR REMOVAL OF THE CASPER INSTRUMENTATION WAS PERFORMED ON 9/29/93.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASPER PLATE AND SCREWS FOR ANT. CERVICAL FUSION Implant BONE PLATE AND SCREWS HRS AESCULAP, AAG NA PLATE: 5586758;SCREWS:UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention