BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIS CANNULATED POLYAXIAL SCREW

    MDR report key: 4190273 · Received October 21, 2014

    Report

    Report Number
    1526439-2014-12015
    Event Type
    Injury
    Date Received
    October 21, 2014
    Report Date
    September 24, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS INDICATED IN THE INITIAL MFG. MEDWATCH REPORT, THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. REVIEW OF X-RAY IMAGES THAT WERE PROVIDED CONFIRMED A CHANGE IN ANGULATION OF THE SCREWS. THE ROOT CAUSE CANNOT BE IDENTIFIED. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    VIPER WAS USED TO TREAT A TRAUMATIC BURST FRACTURE ON LABOR DAY. POST-OPERATIVE IMAGES IN THE ROOM CONFIRM SUCCESSFUL REDUCTION OF THE FRACTURE THROUGH THE UTILIZATION OF THE VIPER COMPRESSION/DISTRACTION RACK. POST OP FOLLOW UP 2 WEEKS LATER: FOUR MIS CANNULATED POLYAXIAL SCREWS FAILED TO HOLD THE DISTRACTION ACHIEVED IN THE OR. NO SAMPLES BEING RETURNED. STILL IMPLANTED. LEVEL(S) OPERATED T12 - L2; LEVEL(S) INSTRUMENTED T12 & L2; CONSTRUCT CONSISTED OF 6X45MM VIPER SCREWS AT T12 AND L2, 80MM PRE-LORDOSED VIPER ROD, AND 4 VIPER SET SCREWS. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE FOUR MIS CANNULATED SCREWS THAT FAILED TO HOLD THE DISTRACTION THAT HAD BEEN ACHIEVED: 1526439-2014-12015, 1526439-2014-12016, 1526439-2014-12017, 1526439-2014-12018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668679 MIS CANNULATED POLYAXIAL SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4) X 2| (B)(4) X 4| (B)(4) X 2