BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE, SPINAL (COBB)

    MDR report key: 2152168 · Received June 23, 2011

    Report

    Report Number
    1226348-2011-00226
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 23, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    FZS
    PMA / PMN Number
    PRE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE SPOON CURETTE BROKE DURING THE SURGERY INTO THE VERTEBRAL AREA. SO THE SURGEON HAD TO SPEND TIME TO FIND THE PRODUCT INSIDE THE PATIENT. THERE WAS NO INJURY TO THE NERVES. IT IS NOT KNOWN HOW LONG THE DELAY WAS IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURETTE, SPINAL (COBB) INSTRUMENTS FZS CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK