BEUDAMED
    FDA Adverse Event Death Summary report: N

    5.5 TI POLYAXIAL WIDE LAG SCREW 8X80MM

    MDR report key: 5548346 · Received April 5, 2016

    Report

    Report Number
    1526439-2016-10256
    Event Type
    Death
    Date Received
    April 5, 2016
    Date of Event
    March 9, 2016
    Report Date
    March 10, 2016
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK111571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT WILL BE REPORTED AS ADVERSE EVENT. THE CAUSE OF DEATH IS UNKNOWN BUT THE REPORTED SCREWS SHOULD NOT BE DIRECTLY RELATED. THE SAMPLES WILL NOT BE RETURNED BECAUSE IT WAS LEFT IN THE PATIENT¿S BODY.THERE IS NO INDICATION THAT THE DEPUY SPINE DEVICES CAUSED OR CONTRIBUTED TO THE EVENT. NO REPORTED MALFUNCTION OR FAILURE IN THE INSTRUMENTS AND IMPLANTS. ALL PATIENT DEATHS REPORTED TO DEPUY SPINE IN WHICH DEPUY SPINE DEVICE(S) HAVE BEEN OR WERE BEING IMPLANTED WILL BE REPORTED AS MDR EVENTS REGARDLESS OF CAUSALITY. 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. SAMPLE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, AN XLIF WAS INITIALLY PERFORMED ON A PATIENT WITH DEGENERATIVE LUMBAR KYPHOSCOLIOSIS. IT WAS SUCCESSFULLY COMPLETED. ON (B)(6) 2016, A POSTERIOR SPINAL FUSION WAS PERFORMED WITH THE REPORTED SCREWS. AFTER DECOMPRESSION AND FUSION FOR T10-SAI WAS COMPLETED, THE PATIENT BECAME CARDIAC ARREST. ON THE FOLLOWING DAY AT 6:30PM, IT WAS INFORMED THAT THE PATIENT DIED. THE CAUSE OF DEATH IS UNKNOWN BUT THE REPORTED SCREWS SHOULD NOT BE DIRECTLY RELATED. THE SAMPLES WILL NOT BE RETURNED BECAUSE IT WAS LEFT IN THE PATIENT¿S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203095 5.5 TI POLYAXIAL WIDE LAG SCREW 8X80MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death