BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOUNTAINEER OC PLATE LARGE

    MDR report key: 3803117 · Received May 9, 2014

    Report

    Report Number
    1526439-2014-11498
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWP
    PMA / PMN Number
    PK049803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS IT WAS NOTED THAT THE MOUNTAINEER OCCIPITAL Y PLATE WAS BROKEN DURING SURGERY . THE PLATE WAS BENT AT THE ANGLE AS INSTRUCTED AND CONNECTED WITH THE LATERAL PLATE TO SET AT THE OCCIPITAL BONE. THEY WERE FIXED PROVISIONALLY WITH SCREWS. WHEN THE JET LAVAGE WAS DONE TO THE SITE, THE SURGEON FOUND THAT A PART OF THE Y PLATE WHICH HAD 3 HOLES VERTICALLY HAD BEEN FOLDED AT THE END SLIT. THE BROKEN PLATE FIXED WITH SCREWS WERE REINFORCED BY A NESPLON CABLE AND LEFT IMPLANTED IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED WITH A FIFTEEN MINUTE DELAY. AFFILIATE REPORTS THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SAMPLE WILL BE RETURNED BECAUSE IT WAS IMPLANTED IN THE PATIENT¿S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281330 MOUNTAINEER OC PLATE LARGE APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 LATERAL PLATE, CATALOG NO. UNKNOWN