BEUDAMED
    FDA Adverse Event Death Summary report: N

    MOSS MIAMI

    MDR report key: 6907298 · Received October 2, 2017

    Report

    Report Number
    1526439-2017-10779
    Event Type
    Death
    Date Received
    October 2, 2017
    Date of Event
    August 31, 2017
    Report Date
    September 6, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    HWR
    UDI-DI
    10705034194455
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    SURGEON INFORMED ME ABOUT THE VIPER SURGERY HE PERFORMED ON (B)(6) 2017. THE FEMALE PATIENT HAD BEEN PROVIDED WITH 5 VIPER SCREWS ON EACH SIDE. SINCE ONLY 8 EXTENSIONS WERE AVAILABLE IN THE SET, THE SURGERY WAS PERFORMED IN A KIND OF MINI OPEN TECHNIQUE. ONE SCREW ON EACH SIDE WAS PLACED WITHOUT AN EXTENSION. BESIDES 2 EXTENSION DISASSEMBLED DURING THE SURGERY AND 2 SCREWS EACH SIDE WERE PLACED WITHOUT EXTENSIONS. WHEN THE ROD PLACING WAS FINISHED (ROD WELL PRE-BENDED), THE INNIES WERE PLACED. THE ROD COULDN'T BE PLACED FAR ENOUGH INTO THE SCREW HEAD AND THE INNIE COULDN'T BE TIGHTENED. THEREFORE PLUNGER (CODE NO. 275015900) MM ROD INTRODUCTION INSTRUMENT WAS USED. SURGEON TRIED TO PLACE THE ROD WITH THE PLUNGER INTO THE SCREW HEAD IN ORDER TO BE ABLE TO TIGHTEN THE INNIE. IN DOING THIS THE SURGEON SLIPPED OFF THE ROD AND THE PATIENT'S AORTA WAS INJURED. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686348 MOSS MIAMI DRIVER, PROSTHESIS HWR DEPUY SYNTHES SPINE 275015900 10705034194455

    Patients

    Seq Age Sex Outcome Treatment
    1 Death