BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163397 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02214
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    September 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.

    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 BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR ANTERIOR L5-S1 FUSION WHERE RHBMP-2 WAS IMPLANTED INSIDE AND OUTSIDE THE INTERBODY CAGES. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2003 , PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: HISTORY OF ATTEMPTED L4-L5 FUSION. L4-L5 PSEUDOARTHROSIS WITH INTRACTABLE POSTSURGICAL MECHANICAL LOW BACK PAIN AND INSTABILITY. DEGENERATIVE DISK DISEASE. THE PATIENT UNDERWENT FOLLOWING PROCEDURES: ANTERIOR EXPOSURE OF LUMBAR SPINE WITH EXPLORATION OF L4-5 FUSION AND REACTION OF PSEUDOARTHROSIS. INTRAOPERATIVE FLUOROSCOPY. SUPERVISION AND INTERPRETATION OF X-RAYS. L4-5 ANTERIOR LUMBAR INTERBODY FUSION WITH APPLICATION OF INTERVERTEBRAL FUSION CAGES WITH BONE MORPHOGENIC PROTEIN. PER OP NOTES, "...16X23 MM LT CAGES WERE OBTAINED. BONE MORPHOGENIC PROTEIN HAD BEEN RECONSTITUTED IN THE USUAL MANNER IN ANTICIPATION OF FUSION AND WAS NOW PLACED WITHIN CAGES. THE LT CAGES WERE THEN ADVANCED INTO THE L4-L5 INTERSPACE UNDER FLUOROSCOPIC GUIDANCE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264180 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA MC111001D

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention