BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEVIEW CERVICAL PLATING SYSTEM

    MDR report key: 2193335 · Received July 28, 2011

    Report

    Report Number
    3003855635-2011-00001
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLATE AND SCREWS WERE REMOVED, THE CERVICAL SPACER WAS LEFT IN DUE TO INDICATIONS OF FUSION. PRODUCT WAS REC'D AND VERIFIED THAT THE LOT DHR INFO DID NOT INDICATE ANY ANOMALIES THAT MAY HAVE ATTRIBUTED TO DEVICE FAILURE. PRODUCT WAS EVALUATED UNDER HIGH MAGNIFICATION AND PHOTOS TAKEN FROM MULTIPLE VIEWS. EVAL DID NOT IDENTIFY ANY ISSUES WITH PRODUCT BEYOND NORMAL WEAR/TEAR EXPECTED DURING IMPLANTATION/ REMOVAL. SURGEON DID NOT PERFORM A DEXA SCAN TO VERIFY BONE QUALITY PRIOR TO SURGERY. SINCE THERE WERE NO INDICATIONS OF ANY DAMAGE OR ACTUAL DEVICE FAILURE, EVAL INDICATES CONFIRMATION CONSISTENT WITH SURGEONS COMMENTS REGARDING KYPHOSIS/OSTEOPOROSIS AS THE CAUSE OF INCIDENT. PRODUCT WAS RETURNED TO PT, PER PT REQUEST. ADD'L LOT NUMBER: 00677.

    Description of Event or Problem · 1

    INITIAL SURGERY DATE (B)(6) 2011. REC'D NOTICE THAT DURING A 10 DAY POST-OP F/U IT WAS DETERMINED THAT THE CERVICAL PLATE AND SCREWS WERE BACKING OUT FROM THE SPINE. SURGEON DID NOT REVISE IMMEDIATELY, BECAUSE SURGEON WAS AWAITING INDICATION OF POSSIBLE FUSION SINCE THE PT WAS ASYMPTOMATIC AND WAS MONITORED UNTIL REMOVAL. REVISION SURGERY OCCURRED ON (B)(6) 2011 AND IMPLANTS WERE FORWARDED TO THE MFR. DURING REVISION SURGERY THE SURGEON FELT THAT INCIDENT MAY BE ATTRIBUTED TO KYPHOSIS AND/OR OSTEOPOROSIS. INTRA-OP VERIFICATION AFFIRMED THAT THE SELF DRILLING CERVICAL SCREWS WERE ENGAGED AND POSTERIOR TO BONE. CERVICAL PLATE LOCKING TABS REMAINED IN LOCKED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEVIEW CERVICAL PLATING SYSTEM NONE KWQ ATLAS SPINE, INC. 70001-022 01387

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention