BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163322 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02201
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    November 14, 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 BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR L5-S1 FUSION WHERE RHBMP-2 WAS PLACED INSIDE AND OUTSIDE OF AN INTERBODY SPACER. 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) 2006: PATIENT PRESENTED WITH THE PRE-OP DIAGNOSIS: L5- S1 DISK DEGENERATION AND UNDERWENT ANTERIOR LUMBAR INTERBODY FUSION USING RHBMP-2/ ACS. PER OP-NOTES:¿¿ THE RETROPERITONEAL SPACE WAS EXPOSED IN THE L5-S1 INTERSPACE. ONCE THE PROPER SPACE WAS IDENTIFIED, DEEP RETRACTORS WERE PLACED AND THE ANTERIOR DISCECTOMY WAS COMPLETED UNDER DIRECT AND FLUOROSCOPIC GUIDANCE. THE INTERSPACE WAS THEN SIZED AND IT WAS FELT THAT A SIZE 17 SPACER WOULD BE APPROPRIATE AND THIS WAS THEN THAWED AND PREPARED. IT WAS THEN FILLED WITH RHBMP-2/ ACS AND IMPACTED INTO THE PLACE UNDER THE DIRECT VISUAL AND FLUOROSCOPIC GUIDANCE. A GOOD FIT WAS OBTAINED, AND THEN A PLATE WAS USED TO STABILIZE THE ENTIRE CONSTRUCT. SUPPLEMENTAL RHBMP-2 WAS PLACED AROUND THE SPACER AND IN BETWEEN THE PLATE AND THE SPACER ITSELF. THE DEEP RETRACTORS WERE THEN REMOVED AND THE INCISION WAS CLOSED. THE PATIENT TOLERATED THE PROCEDURE WELL.. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264640 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention