BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIFF

    MDR report key: 1833849 · Received August 30, 2010

    Report

    Report Number
    2032593-2010-00010
    Event Type
    Other
    Date Received
    August 30, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 27, 2010
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K083338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, SEASPINE WAS CONTACTED AND INFORMED THAT THERE WAS A REVISION. REASON, PART NUMBERS, PRODUCT INFORMATION, PATIENT INFORMATION WAS ALL UNKNOWN. ON (B)(6) 2010 SEASPINE REP CONTACTED SEASPINE TO REPORT THAT THE REVISION WAS PERFORMED TO REMOVE A BROKEN ALLOGRAFT AND A CARDIFF ANTERIOR PLATE. TWO OF THE THREE SCREWS APPEARED TO HAVE LOOSENED ON THE PLATE AS WELL. PRODUCT PART NUMBERS AND LOT NUMBERS STILL NOT AVAILABLE, BUT DECISION WAS MADE TO REPORT AS AN MDR BASED ON THE NEW INFORMATION. SEASPINE CONTACTED THE REP AGAIN ON (B)(4) 2010 TO ASK FOR PATIENT IDENTIFIER IN ORDER TO DETERMINE THE ACTUAL PRODUCT USED IN THE CASE. THE HOSPITAL DID NOT SAVE THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIFF APPLIANCE, FIXATION, SPINAL INTERVERTERBR KWQ SEASPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention