BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3190382 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02531
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    December 12, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH: LUMBAR HERNIATED NUCLEUS PULPOSUS OF RIGHT L5-S1 FORAMINAL. LUMBAR RADICULOPATHY. LUMBAR SPONDYLOLISTHESIS. 4) OBESITY AND PATIENT UNDERWENT FOLLOWING PROCEDURES: TRANSFORAMINAL LUMBAR INTERBODY FUSION, L5-S1. FAR LATERAL DECOMPRESSION FOR HERNIATED DISC, L5-S1. INTERBODY DEVICE, L5-S1. POSTERIOR LUMBAR FUSION, L5-S1. POSTERIOR INSTRUMENTATION OF BILATERAL PEDICLE SCREWS, L5-S1 LOCAL ALLOGRAFT. ALLOGRAFT (BONE MORPHOGENIC PROTEIN/BONE GRAFT/CROUTONS). INTRAOPERATIVE NEUROMONITORING. AS PER OP NOTES ¿TRAIL SIZING WAS ACCOMPLISHED, AND APPROPRIATE SIZE INTERBODY WAS PACKED WITH BONE MORPHOGENIC PROTEIN, DISC SPACE PACKED WITH ALLOGRAFT AND THEN INTERBODY PLACED¿. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1, AS WELL AS A POSTERIOR LUMBAR INTERBODY FUSION AT L5-S1 USING RHBMP-2/ACS MIXED WITH ALLOGRAFT, MASTERGRAFT, AND CROUTONS. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH INJURIES, INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVEREDFROM HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290813 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention