BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEOPARD IMPLANT 5 DEG, LOR, 28X8

    MDR report key: 2497107 · Received March 20, 2012

    Report

    Report Number
    1526439-2012-00056
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    March 12, 2012
    Report Date
    April 9, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIONS CAN BE MADE AT THIS TIME. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. THE MOST LIKELY CAUSE OF THE EVENT IS ATYPICAL FORCE PLACED ON THE CAGE DURING INSERTION. THIS TYPE OF EVENT IS NOT UNANTICIPATED AND THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE WARNS AGAINST THE USE OF ATYPICAL FORCE. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION WAS PERFORMED ON THE HALF OF THE CAGE THAT WAS REMOVED FROM THE PATIENT. VISUAL EXAMINATION FOUND BREAKAGE OCCURRED IN A SIDE CHAMBER WITH THE I-BEAM STILL INTACT. THE LOT CODE IS ILLEGIBLE DUE TO THE PRESENCE OF GOUGES OBLITERATING THE INFORMATION. AS A RESULT, REVIEW OF THE LOT HISTORY RECORDS COULD NOT BE PERFORMED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THE MOST LIKELY CAUSE OF THE EVENT IS ATYPICAL FORCE PLACED ON THE CAGE DURING INSERTION. THIS TYPE OF EVENT IS NOT UNANTICIPATED AND THE INSTRUCTIONS-FOR-USE (IFU) SUPPLIED WITH THE DEVICE WARNS AGAINST THE USE OF ATYPICAL FORCE.

    Description of Event or Problem · 1

    SALES REP REPORTED THE PATIENT HAD AN EXTREMELY COLLAPSED DISC SPACE. DURING INSERTION, THE LEOPARD CAGE BROKE IN HALF, CAUSING A DURAL TEAR WHICH THE REP ESTIMATED TOOK AN ADDITIONAL 30 MINUTES TO REPAIR. THE HALF OF THE CAGE THAT WAS ALREADY IMPACTED INTO THE DISC SPACE REMAINS IN THE PATIENT. ACCORDING TO THE SURGEON, THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEOPARD IMPLANT 5 DEG, LOR, 28X8 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention