BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2841327 · Received November 21, 2012

    Report

    Report Number
    1030489-2012-02419
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    March 1, 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).

    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

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

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    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 "PAIN, THE NEED TO HAVE ANOTHER SURGERY, AS WELL AS PHYSICAL LIMITATIONS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH C4-5, 5-6, 6-7 DISC HERNIATIONS WITH CORRESPONDING RADICULOPATHIES AND UNDERWENT THE FOLLOWING PROCEDURES: ANTERIOR CERVICAL APPROACH FOR C4-5, 5-6, 6-7 ANTERIOR CERVICAL DISCECTOMIES, OSTEOPHYTECTOMIES AND ARTHRODESIS C4-5, C5-6, 6-7 USING TRICORTICAL STRUCTURE GRAFT REQUIRING SHAPING AND SEGMENTAL SCREW INSTRUMENTATION. AS PER OP-NOTES,¿ THE DISC HERNIATION AND THICKENED LIGAMENT WERE BREACHED USING A CURETTE AND RESECTED USING 2- AND 3-MM PUNCHES INTO THE NEURAL FORAMEN WHICH WAS PALPATED AND IT WAS FOUND TO BE OPEN BILATERALLY. THE ENDPLATES WERE PREPARED FOR GRAFT ACCEPTANCE. A 5-MM GRAFT WAS THEN CUT FOR LORDOTIC CURVE, PACKED WITH BONE MORPHOGENIC PROTEIN AND IMPACTED INTO POSITION AT C5-6. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED FROM THE FACILITY.

    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 M110715AAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R