BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3172086 · Received June 17, 2013

    Report

    Report Number
    1030489-2013-02330
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    November 21, 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.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2007: PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSIS OF DEGENERATIVE DISK DISEASE, L5-S1 AND POSITIVE CONCORDANT DISKOGRAM, L 5-S1 AND UNDERWENT ANTERIOR LUMBAR INTERBODY DISKECTOMY AND FUSION, L5-S1, INSERTION OF INTERVERTEBRAL CAGE ON THE RIGHT AT L5-S1, INSERTION OF INTERVERTEBRAL BODY CAGE ON THE LEFT AT L5-S1. PER OPERATIVE NOTES: A 11 BLADE WAS USED TO MAKE AN ANNULOTOMY IN THE DISK THE ENTIRE DISK WAS REMOVED USING COBB ELEVATOR FOLLOWED BY VARIOUS ANGLED CURETTES AND SHAVERS BACK TO THE POSTERIOR LATERAL CORNER AS WELL AS BACK TO THE POSTERIOR ASPECT OF THE DISK. FOLLOWING THIS THE DOUBLE BARRELLED CAGE DEVICE WAS PLACED AND IMPACTED INTO PLACE. THE DISTRACTORS WERE THEN PUT IN AND A REAMER ON THE RIGHT SIDE WAS USED TO REAM BACK TO 32 MM. FOLLOWING THIS A 16 MM X 26 MM CAGE WAS PLACED AND COUNTERSUNK 3 MM. ATTENTION WAS TURNED TO THE LEFT SIDE WHERE THE DISTRACTOR WAS REMOVED AND THE INTERVERTEBRAL BODY DISK SPACE WAS REAMED TO 32 MM FOLLOWED BY PLACEMENT OF A 16 X 32 MM CAGE. THOROUGH IRRIGATION WAS THEN PERFORMED. THE CAGES WERE FILLED WITH BONE MORPHOGENIC PROTEIN AS WELL AS SOME PUTTY IN BETWEEN THE DISK IN BETWEEN THE CAGES. PATIENT TOLERATED THE PROCEDURE WELL. NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT AN L5-S1 ANTERIOR FUSION WHERE RHBMP-2 WAS MIXED WITH BONE PUTTY. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273825 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110605AAB

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention