BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2955350 · Received February 11, 2013

    Report

    Report Number
    1030489-2013-00444
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    May 11, 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): 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.

    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)(6) 2010: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: L4-5 AND L5-S1 DEGENERATIVE DISK DISEASE; DISCOGENIC LOW BACK PAIN; FACET HYPERTROPHY WITH FORAMINAL STENOSIS; INCOMPETENT DISK UNDER AXIAL LOAD AT BOTH LEVELS; CHRONIC LUMBAR BACK PAIN. THE PATIENT UNDERWENT THE FOLLOWING PROCEDURES: L4, L5 AND S1 LAMINECTOMIES; L4-5 AND L5-S1 DISKECTOMY; INTERBODY POSTEROLATERAL INSTRUMENTED FUSION WITH CAGES, AUGMENTED WITH PEDICLE SCREWS AND PEEK RODS; AUTOGENOUS BONE FUSION WITH RHBMP-2/ACS; INSTRUMENTATION WILL BE DISCUSSED; FOLEY CATHETERIZATION. THE PATIENT PRESENTED WITH THE FOLLOWING POST-OP DIAGNOSIS: L4-5 AND L5-S1 DEGENERATIVE DISK DISEASE; DISCOGENIC LOW BACK PAIN; FACET HYPERTROPHY WITH FORAMINAL STENOSIS; INCOMPETENT DISK UNDER AXIAL LOAD AT BOTH LEVELS; CHRONIC LUMBAR BACK PAIN; S1 MIDLINE DURAL TEARS, #2, BOTH REPAIRED WATERTIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59752 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