BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI SPINAL SYSTEM

    MDR report key: 7819164 · Received August 27, 2018

    Report

    Report Number
    3004774118-2018-00141
    Event Type
    Injury
    Date Received
    August 27, 2018
    Date of Event
    July 12, 2018
    Report Date
    July 13, 2018
    Manufacturer
    K2M INC.
    Product Code
    KWP
    PMA / PMN Number
    K133944
    Adverse Event
    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. THE DISTAL END OF THE ROD DISPLAYED GROOVES INDICATIVE OF SURFACE DEFORMATION BY ROD TRANSLATION. THIS MAY HAVE OCCURRED BECAUSE THE AXIAL GRIPPING FORCE OF THE SCREW WAS EXCEEDED DURING FLEXION OF THE CONSTRUCT.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH RODS WERE REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2018. (RELATED TO 3004774118-2018-00118).

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION BUT EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF EVALUATION OF THE SUBJECT PART, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON 7.13.2018 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE IN WHICH RODS WERE REMOVED. REVISION SURGERY TOOK PLACE (B)(6) 2018 (RELATED TO 3004774118-2018-00118).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660509 DENALI SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM KWP K2M INC. ELTB, FDBC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 101-10001 LOT GDWN| 101-10001 LOT GHGE| 101-10001 LOT GHGE, GDWM| 101-6570 LOT FDBC| 101-90219 BPMN057| 101-90219 LOT ALJC044| 101-90219 LOT ALJC044, BPMN057| 101-10001 LOT GHGE, GDWM| 101-90219 LOT ALJC044, BPMN057