BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDUS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 6932689 · Received October 9, 2017

    Report

    Report Number
    3005977257-2016-00002
    Event Type
    Malfunction
    Date Received
    October 9, 2017
    Date of Event
    February 22, 2016
    Report Date
    February 22, 2016
    Manufacturer
    SPINEFRONTIER, INC
    Product Code
    KWQ
    PMA / PMN Number
    K121060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPINE FRONTIER EMPLOYEE WHO WAS PRESENT DURING SURGERY NOTED THAT THE CLINICIAN DID NOT DRILL PRIOR TO SCREW INSERTION, INSTEAD HE USED AN AWL INSTRUMENT TO CREATE A PILOT HOLE. ADDITIONALLY, A GUIDE WAS NOT USED WITH THE AWL AS RECOMMENDED BY THE SURGICAL TECHNIQUE. A REVIEW OF THE MANUFACTURING LOT FOR BB13 REVEALED THAT THE LOT PASSED ALL INSPECTIONS AND WAS RELEASED ON 6/22/2015. AN INVESTIGATION INTO THIS OCCURRENCE IDENTIFIED MISUSE AS THE ROOT CAUSE OF THIS OCCURRENCE.

    Description of Event or Problem · 1

    SPINEFRONTIER RECEIVED INFORMATION FORM A SALES REPRESENTATIVE STATING THAT THE THREADS OF THE INVUE SCREW SHEARED OFF DURING SURGERY WHILE INSERTING THE SCREW THROUGH THE PLATE INTO THE VERTEBRA BODY. THE SHEARED OFF SECTION WAS REMOVED FROM THE WOUND. THE PATIENT SEX, AGE AND WEIGHT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707982 INDUS ANTERIOR CERVICAL PLATE SYSTEM INDUS ANTERIOR CERVICAL PLATE SYSTEM KWQ SPINEFRONTIER, INC IM71059-02 BB13

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention