BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3138703 · Received May 30, 2013

    Report

    Report Number
    1030489-2013-01970
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    June 26, 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

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE USED 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. (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES OR MEDICAL RECORDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    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

    IT WAS REPORTED THAT ON: (B)96) 2007: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: DEGENERATIVE DISC DISEASE OF THE LUMBAR SPINE. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: POSTERIOR LUMBAR INTERBODY FUSION L3-4, L4-5 AND L5-S1 WITH BILATERAL DECOMPRESSIONS L3-4, L4-5, L5-S1, PEDICLE SCREW FIXATION. AS PER OPERATIVE NOTES, ¿7-MM TRIAL SPACER WAS FOUND TO BE OF THE APPROPRIATE SIZE THEREFORE A 7-MM PEEK SPACER WAS PREPARED WITH THE PATIENTS' OWN AUTOGRAFT BONE AS WELL AS BMP (BONE MORPHOGENIC PROTEIN) AND PLACED WITHIN THE DISC SPACE.¿ NO INTRA-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238637 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other