BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENGAL STACK STD LOR 32MM

    MDR report key: 9491909 · Received December 18, 2019

    Report

    Report Number
    1526439-2019-52720
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    March 7, 2019
    Report Date
    March 7, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    MAX
    UDI-DI
    10705034060880
    PMA / PMN Number
    K140759
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. INITIAL REPORTER IS A DEPUY SALES REPRESENTATIVE. A PRODUCT INVESTIGATION WAS COMPLETED: THE BENGAL 32MM LORDOTIC CAGE WAS RETURNED. THE EXTERIOR OF THE CAGE FEATURED A WORN, GRAYISH SURFACE. THE INTERIOR OF THE CAGE FEATURES A SIMILAR ENVIRONMENT, BUT A THIN LAYER OF THE CAGE¿S, MATERIAL HAS BEGUN TO STRIP AND PEEL FROM THE SURFACE. THIS APPEARS TO BE THE RESULT OF THE ENVIRONMENT THE CAGE HAS EXPERIENCED, DUE TO THE SWEEPING NATURE OF THE DAMAGE AND THE LACK OF TOOL MARKS. IT IS BELIEVED THAT THIS MAY BE THE RESULT OF STERILIZING THE CAGE AT HIGH TEMPERATURES AND/OR USING HARSH, ABRASIVE DETERGENT DURING AUTOCLAVE. A REVIEW OF THE RECEIVING INSPECTION RECORD (RI) WAS PERFORMED ON THE BENGAL 32MM LORDOTIC CAGE. NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. AS A RESULT, A REVIEW OF THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS CAGE THAT COULD CONTRIBUTE TO THE PROBLEM REPORTED BY THE CUSTOMER. THIS CAGE WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. THE ROOT CAUSE OF THE SPLITTING MATERIAL AND DISCOLORATION ON THE SURFACE OF THE CAGE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE EXPOSURE TO A HOT, ALKALINE SOLUTION DURING WASHING, SUBSEQUENTLY LEADING TO DAMAGE. SURGICAL INSTRUMENT REPROCESSING INSTRUCTIONS FOR USE STATES THAT AUTOCLAVING THE DEVICES WITH ABRASIVE, HIGHLY ALKALINE DETERGENTS HAS BEEN KNOWN TO RESULT IN DAMAGE TO THE CAGE. NO CORRECTIVE AND PREVENTIVE ACTION (CAPA) IS NECESSARY AT THIS TIME AS NO ISSUES COULD BE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS PRODUCT. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THE CAGE CONTAINED WHAT LOOKED LIKE FLAKING CARBON FIBER WITHIN THE IMPLANT. THERE WAS A LARGE AMOUNT OF DEBRIS THAT CAME OUT FROM INSIDE THE CAGE. THIS REPORT IS FOR A BENGAL STACK CAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283333 BENGAL STACK STD LOR 32MM INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX DEPUY SPINE INC 177306132 5086154 10705034060880

    Patients

    Seq Age Sex Outcome Treatment
    1