BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC E-PLATE INSERT FOR FJ885R & FJ889R

    MDR report key: 2982216 · Received November 17, 2006

    Report

    Report Number
    2916714-2006-00077
    Event Type
    Malfunction
    Date Received
    November 17, 2006
    Date of Event
    October 20, 2006
    Report Date
    November 17, 2006
    Manufacturer
    AESCULAP, INC.
    Product Code
    KWQ
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE AND ALL OF THE AVAILABLE INFO HAS BEEN FORWARDED FOR ANALYSIS TO THE MFR, AESCULAP, (B)(4). CLASS 2 PRODUCT-MEANT TO STAY IN AS FIXATION.

    Description of Event or Problem · 1

    SURGEON HAD A DIFFICULT TIME IMPLANTING BOTH A CRANIAL AND CAUDAL E-PLATE DURING A CASE. SURGEON CLEARED AWAY AS MUCH BONE MATERIAL AS HE COULD. THE PLATE ADAPTATION TOOL COULDN¿T JOIN THE E-PLATES TO THE ABC PLATE USING THE STANDARD TECHNIQUES DESCRIBED IN PRODUCT GUIDES. SURGEON TRIED UNSUCCESSFULLY TO USE THE ADAPTING TOOL. TWO INSERTION PINS (FJ892R-CAUDALLY) WERE BROKEN AND EVENTUALLY HAD TO PLACE A BONE TAMP (INSTRUMENT) IN THE CENTER HOLD OF THE CAUDAL PLATE (FJ866T) AND ¿HAMMER¿ THE E-PLATE ONTO THE ABC PLATE; 14MM ABC2 SCREWS WERE PLACED TO FINISH THE CAUDAL PORTION OF THE CASE. A SIMILAR SITUATION OCCURRED WITH THE CRANIAL E-PLATE. THE ADAPTATION TOOL COULD NOT COMPLETELY SECURE THE E-PLATE TO THE ABC PLATE. SURGEON CLEARED AS MUCH BONE MATERIAL AS HE LIKED TO PREPARE FOR THE E-PLATE. WHEN HE ATTEMPTED TO AFFIX THE CRANIAL PORTION TO THE ABC PLATE, HE REMARKED THAT THE LATERAL EDGE OF THE E-PLATE (FJ873T) APPEARED TO BE BENDING UPWARD/OUTWARD-PEELING OR FLARING. AS WITH THE CAUDAL E-PLATE, HE USED A MALLET AND ANOTHER TOOL TO CONNECT THE CRANIAL E-PLATE. ONCE THE PLATE WAS IN PLACE, 12MM ABC2 SCREWS SECURED THE CONSTRUCT. THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENT. SURGEON NOTED THE LATERAL POST IMPLANT X-RAY ¿LOOKED GOOD¿ AND HAD ¿LORDOSIS¿. PROCEDURE PROLONGED TEN MINUTES OR LESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABC E-PLATE INSERT FOR FJ885R & FJ889R APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ AESCULAP, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1