BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASPIAN® SPINAL SYSTEM

    MDR report key: 7333496 · Received March 13, 2018

    Report

    Report Number
    3004774118-2018-00025
    Event Type
    Injury
    Date Received
    March 13, 2018
    Date of Event
    February 14, 2018
    Report Date
    June 13, 2019
    Manufacturer
    K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
    Product Code
    KWP
    PMA / PMN Number
    K081107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. PARTS WERE RETURNED AND EVALUATED ALONG WITH RELEVANT X-RAYS. ANALYSIS OF INCLUDED X-RAY IMAGES SHOW A RADIOLUCENCY AROUND THE SUBJECT SCREW, PROXIMAL TO THE POINT OF FAILURE. THIS SUGGESTS DYNAMIC MOTION MAY HAVE EXISTED WITHIN THE CONSTRUCT. THE SHAFT OF THE SCREW WAS FRACTURED APPROXIMATELY 13 MM DISTAL TO THE HEAD ASSEMBLY. THE FRACTURE FACE INDICATES FAILURE DUE TO SUDDEN BRITTLE OVERLOAD.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SCREW IMPLANTED IN THE RIGHT T1 PEDICLE, WAS FOUND TO BE BROKEN APPROXIMATELY SIX MONTHS POST-OPERATIVELY.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE SCREW WAS NOT RETURNED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE SCREW WAS NOT RETURNED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A BROKEN SCREW WAS DISCOVERED POST-OPERATIVELY.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A BROKEN SCREW WAS DISCOVERED APPROXIMATELY A YEAR POST-OPERATIVELY.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A BROKEN SCREW WAS DISCOVERED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178105 CASPIAN® SPINAL SYSTEM APPLIANCE, FIXATION SPINAL INTERLAMINAL KWP K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION BCBW

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 1101-03530M LOT CPVH| 1101-10001 LOT EAGT| 1101-10001 LOT EJAE| 1101-10001 LOT FAFH| 1101-63580 LOT DWRM| 1101-63580 LOT FBEK