BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALENCIA MIS

    MDR report key: 16040720 · Received December 22, 2022

    Report

    Report Number
    3009049161-2022-00002
    Event Type
    Injury
    Date Received
    December 22, 2022
    Date of Event
    January 20, 2022
    Report Date
    December 6, 2022
    Manufacturer
    ALTUS SPINE
    Product Code
    KWQ
    PMA / PMN Number
    K151648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VIA INTERVIEW, IT WAS DETERMINED THAT THE SURGICAL TECHNIQUE GUIDE WAS NOT FOLLOWED BECAUSE A COUNTER TORQUE INSTRUMENT WAS NOT IMPLEMENTED. THE CAP (915-1911) WAS RETRIEVED BY THE MANUFACTURER UPON REVISION SURGERY; HOWEVER, INVESTIGATION FOUND THE CAP TO BE STRUCTURALLY INTACT AND ABLE TO CARRY FULL LOAD. THERE WAS NO SIGN OF MISUSE AND IT SHOWED EVIDENCE OF BEING TORQUED TO AN INDETERMINATE LOAD. BENCH TESTING WAS PERFORMED TO ATTEMPT TO REPRODUCE THE ISSUE. IT WAS FOUND THAT USING THE COUNTER TORQUE, AS INTENDED, MINIMIZES TULIP HEAD DEFORMATION WITHOUT ADVERSELY AFFECTING BREAKAWAY TORQUE. UPON INVESTIGATING ALL ASSOCIATED TORQUE LIMITING HANDLES (905-0012), ONE WAS VERIFIED TO BE LOWER THAN INSPECTION PLAN TOLERANCE (84.5 - 94.5 IN-LBS) AT 80.4 IN-LBS.; HOWEVER, THIS DEVIATION ALONE WOULD NOT RESULT IN THE BACKING OUT OF A CAP BECAUSE THE MANUFACTURER DESIGN FILE DEMONSTRATES THAT A FINAL TORQUE AS LOW AS 76.5 INCH-LBS STILL RESULTS IN EQUIVALENT PERFORMANCE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DURING ROUTINE FOLLOW-UP, PATIENT X-RAY PRESENTED LOOSE CONSTRUCT (LOCKING CAP). UPON REVISION, THE CAP (915-1911) WAS RETURNED TO THE MANUFACTURER BY THE HEALTH CARE PROVIDER AND SHOWED SIGNS OF INDETERMINATE TORQUING. THE REVISION WAS SUCCESSFUL AND THERE HAS BEEN NO REPORT OF PERMANENT DAMAGE/IMPAIRMENT TO THE PATIENT. VIA INTERVIEW, IT WAS DETERMINED THAT THE SURGICAL TECHNIQUE GUIDE WAS NOT FOLLOWED BY THE USER BECAUSE A COUNTER TORQUE INSTRUMENT WAS NOT IMPLEMENTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A SUPPLEMENTAL MEDWATCH WILL BE FILED AS APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1740976 VALENCIA MIS LOCKING CAP KWQ ALTUS SPINE AP23821

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention