BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2840237 · Received November 20, 2012

    Report

    Report Number
    1030489-2012-02397
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    February 8, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    (B)(4).

    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 THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT HAS "SIGNIFICANT PAIN, MAJOR RESPIRATORY PROBLEMS", AND [PATIENT] HAS TO VISIT DOCTOR FREQUENTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2008: THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SEVERE ADJACENT SEGMENT DEGENERATIVE STENOSIS AT L3-L4. RESTRUCTURING NEUROGENIC CLAUDICATION. STATUS POST POSTEROLATERAL FUSION AND DECOMPRESSION AT L4-L5 (PERFORMED IN 2004) AND UNDERWENT THE FOLLOWING PROCEDURES: L3-L4 POSTEROLATERAL ARTHRODESIS WITH LOCALLY OBTAINED AUTOGRAFT, CORTICAL CANCELLOUS ALLOGRAFT AND RHBMP-2/ACS. REMOVAL OF INSTRUMENTATION, L3 TO L5. EXPLORATION OF FUSION L4-L5. BILATERAL PEDICLE SCREW INSERTION AT L3. BILATERAL PEDICLE SCREW INSTRUMENTATION L3 TO L5. COMPLETE L3 LAMINECTOMY AND RESIDUAL L4 LAMINECTOMY FOR DECOMPRESSION OF THE CAUDA EQUINA. AS PER OPERATIVE NOTES,¿ DURING DECOMPRESSION, A MEDIUM SIZED KIT OF BMP (BONE MORPHOGENIC PROTEIN) WAS PREPARED ON THE BACK OPERATING TABLE. TWO COLLAGEN SPONGES WERE THEN PLACED DIRECTLY IN CONTACT WITH THE FUSION MASS AT L4 TO THE TRANSVERSE PROCESS AT L3. THEN 50ML OF CORTICAL CANCELLOUS MORSELIZED ALLOGRAFT WAS MIXED WITH THE MORSELIZED LOCALLY OBTAINED AUTOGRAFT AND DIVIDED INTO TWO EQUAL PORTIONS. THIS GRAFT MATERIAL WAS THEN PACED INTO THE POSTEROLATERAL GUTTERS BILATERALLY AT L3-L4 WITH PICKUPS AND IMPACTORS OVER THE BMP SPONGES.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC M110704AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R