BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3D CROWN MAYFIELD SLIDER ASSEMBLY

    MDR report key: 4330295 · Received December 15, 2014

    Report

    Report Number
    1526439-2014-12215
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    October 20, 2014
    Report Date
    December 5, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    IQK
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED 3D CROWN MAYFIELD SLIDER ASSEMBLY REVEALED THAT THE SLIDER ASSEMBLY HAD FRACTURED. RESULTS OF FRACTURE ANALYSIS INDICATED THAT THE FRACTURED SURFACE EXHIBITS A ROUGH GRAINY PATTERN THAT APPEARS FAIRLY UNIFORM. THIS PATTERN IS INDICATIVE OF A STATIC BRITTLE FAILURE. NO MATERIAL DEFECTS OR OTHER ABNORMALITIES WERE OBSERVED IN THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DISCREPANCIES. A REVIEW OF THE COMPLAINT TREND ANALYSIS WAS PERFORMED AND NO SYSTEMIC TREND WAS IDENTIFIED AS A RESULT OF THE ANALYSIS. THE ROOT CAUSE OF THE BROKEN 3D CROWN MAYFIELD ADAPTER CLAMP SLIDER CANNOT POSITIVELY BE DETERMINED. HOWEVER, THE FRACTURE ANALYSIS REPORT NOTED THAT THE FRACTURE IS INDICATIVE OF A STATIC BRITTLE FAILURE. BASED ON THE LOT MANUFACTURE DATE, THE DEVICE HAD BEEN IN THE FIELD FOR APPROXIMATELY TEN YEARS. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER AND NO SYSTEMIC TRENDS HAVE BEEN OBSERVED, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    THE LOT NUMBER THAT WAS PROVIDED TO DEPUY SYNTHES SPINE IS INCORRECT FOR THIS ITEM. THE SECTION OF THE 3D CROWN MAYFIELD SLIDER ASSEMBLY THAT CONTAINED THE LOT CODE HAD BROKEN OFF FROM THE DEVICE SO THAT THE LOT CODE IS UNKNOWN. 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 · 1

    CUSTOMER HAD REPORTED THAT THE 3D CROWN MAYFIELD SLIDER ASSEMBLY CLAMP BROKE DURING SURGERY WITH NO ADVERSE CONSEQUENCES TO THAT PATIENT AND NO RESULTING DELAY. HOWEVER, ON (B)(6) 2014, USER FACILITY REPORT NUMBER (B)(4) (ATTACHED) WAS RECEIVED FROM THE FDA WITH THE FOLLOWING EVENT DESCRIPTION: POSTERIOR CERVICAL FUSION REVISION OF INSTRUMENTATION WITH HALO TRACTION AND USE OF ALLEN C-FLEX POSITIONER. HALO TRACTION WAS PLACED ON FIRST SURGERY. PATIENT WAS TRANSFERRED TO OPEN JACKSON AND POSITIONED INTO HALO C-FLEX FOR SURGERY TO BEGIN. THREE DAYS LATER, PATIENT BACK IN OR FOR ANOTHER SURGERY. DURING THIS SURGERY, SURGEON NEEDED TO REPOSITION THE PATIENT'S NECK AND HEAD. AT THIS POINT, THE BLUE CLAMP THAT SECURES THE HALO TO THE C-FLEX POSITIONER BROKE AND CAUSED THE HEAD TO COME FREE (DOCTOR HAD HOLD OF THE HALO SECURING THE HEAD AND NECK) THIS ISSUE NEEDS TO BE RESOLVED. THIS ISSUE CAUSED A VERY CONCERNING SAFETY ISSUE SINCE THERE IS NO LIFESPAN ON THE CLAMPS. I HAVE BEEN TRYING TO FIND OUT IF THE MANUFACTURER RECOMMENDS US GETTING NEW CLAMPS SO I CAN CONTACT SURGERY DEPARTMENT TO ORDER MORE. I HAVE ASKED THE QUESTION A COUPLE TIMES AND I AM NOT GETTING RESPONSE FROM THE MANUFACTURER. AS A RESULT OF THIS NEW/DIFFERENT INFORMATION THAT WAS RECEIVED FROM THE FDA, THIS MFG. MEDWATCH REPORT IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820279 3D CROWN MAYFIELD SLIDER ASSEMBLY ORTHOSIS, CERVICAL IQK DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1