BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIDENCE SPINAL CMT SYS, 11C

    MDR report key: 3170967 · Received June 14, 2013

    Report

    Report Number
    1526439-2013-18917
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NDN
    PMA / PMN Number
    PK060300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLES ARE NOT BEING RETURNED FOR EVALUATION AS THE CEMENT WAS IMPLANTED IN THE PATIENT. THE DEVICE HISTORY RECORDS (DHR¿S) IDENTIFIED NO DISCREPANCIES. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. REVIEW BY QUALITY ENGINEER WAS CONDUCTED AND NO CONCLUSIONS WERE DRAWN AS THE CONFIDENCE KITS WERE NOT RETURNED FOR EVALUATION. A REVIEW WITH MEDICAL DIRECTOR WAS CONDUCTED AND PER PHONE DISCUSSION WITH THE SURGEON IT WAS NOTED THAT PATIENT DIAGNOSIS WAS A THORACOLUMBAR KYPHOSIS AND THE PLANNED PROCEDURE WAS T7-L2 POSTERIOR SPINAL FUSION. PAST MEDICAL HISTORY: MYOCARDIAL INFARCTION (DATE UNSPECIFIED), TRIPLE BYPASS 2004, MYOCARDIAL INFARCTION 2010, 6 CORONARY STENTS. HISTORY OF DORSAL COLUMN STIMULATOR IMPLANTED AT T11-T12 AREA, PATIENT DEVELOPED COMPRESSION FRACTURE WITH PROGRESSIVE KYPHOSIS. HAIRPIN POSTURE, WALKING WITH 2 CANES. PRE-OP WORK-UP FROM ENDOCRINOLOGIST FOR OSTEOPENIA; OBTAINED CARDIOLOGIST CLEARANCE. PT. BECAME BRADYCARDIC/HYPOTENSIVE. WITHOUT THE PRODUCT SAMPLES WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. THEREFORE, IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEPUY SYNTHES SPINE WAS NOTIFIED OF A PATIENT DEATH WHICH OCCURRED FOLLOWING A SURGERY IN WHICH THE CONFIDENCE SPINAL CEMENT SYSTEM WAS USED. THE PATIENT WAS A (B)(6) FEMALE WITH A HISTORY OF CARDIAC STENT, AORTIC ANEURISM, OSTEOPOROSIS, AND VERTEBRAL COMPRESSION FRACTURES. ON (B)(6) 2013 THE PATIENT UNDERWENT A T8-L2 FUSION USING A COMPETITOR'S IMPLANT DEVICES. THE SURGEON INTENDED TO AUGMENT THE COMPETITORS SCREWS USING THE CONFIDENCE SPINAL CEMENT SYSTEM. THE SURGEON WAS ADVISED BY THE DEPUY SYNTHES SPINE REPRESENTATIVE THAT THE USE OF THE CONFIDENCE SPINAL CEMENT SYSTEM FOR SCREW AUGMENTATION IS ¿OFF-LABEL¿ USE. GUIDE WIRES WERE PLACED AND THEN THE CONFIDENCE CEMENT WAS INJECTED FOLLOWED BY THE PLACEMENT OF SCREWS OVER THE GUIDE WIRE. AT OR ABOUT THE TIME THE FINAL SCREW WAS BEING PLACED THE ANESTHESIOLOGIST REPORTED NO PULSE OX. BLOOD LOSS WAS ALSO REPORTED TO INCREASE FROM 400 CC TO 800 CC. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS TRANSFERRED TO A BED. IT WAS REPORTED THAT CPR WAS INITIATED AND THE PATIENT WAS ABLE TO BE RESUSCITATED, STABILIZED, AND TRANSFERRED TO THE ICU. THE PATIENT WAS REPORTED TO HAVE EXPIRED LATER THAT NIGHT. POST-MORTEM EXAMINATION WAS DECLINED BY THE PATIENT¿S FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271295 CONFIDENCE SPINAL CMT SYS, 11C CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SYNTHES SPINE HPFBL1, HPFBMW

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other