BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3768004 · Received April 23, 2014

    Report

    Report Number
    1030489-2014-02269
    Event Type
    Injury
    Date Received
    April 23, 2014
    Report Date
    April 4, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    (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 UNDERWENT AN L5-S1 TLIF SPINAL FUSION SURGERY IN USING RHBMP-2/ACS. IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT DEVELOPED UNCONTROLLED BONE GROWTH, RADICULITIS, PAIN, AND MENTAL ANGUISH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007 PATIENT UNDERWENT THE FOLLOWING PROCEDURES: PERCUTANEOUS ENDOSCOPIC FUSION LEFT L5-S1 MINIMAL ACCESS SPINAL TECHNOLOGY (MAST) TRANSFORAMINAL LUMBAR INTERBODY FUSION USING RH BMP-2/ACS; POSTERIORFUSION LEFT L5-S1 USING MORSELLIZED LOCAL BONE GRAFT AND RHBMP-2/ACS; INTERBODY FIXATION USING INTERBODY CAGE 12 X 22 MM; PERCUTANEOUS SEXTANT PEDICLE FIXATION L5-S1 USING 5.5MM TITANIUM ROD AND 6.5MM MULTIAXIAL SCREWS. PREOPERATIVE, POSTOPERATIVE DIAGNOSIS: CHRONIC LEFT LUMBAR REFERRED SYNDROME- SECONDARY TO RECURRETNT DISC HERNIATION HERNIATED NUCLEUS POLPUSUS (HNP) LEFT L5-S1. OPERATIVE FINDINGS: POSTEROLATERAL HNP, RECURRENT LEFT L5-S1. PER OP-NOTES: ¿.. RHBMP-2/ACS SPONGE WAS THEN PLACED IN THE ANTERIOR HALF OF THE DISC FOLLOWED BY PLACEMENT OF THE 12 X 22 MM CAGE STUFFED WITH RHBMP-2/ACS, PLACED IN THE DISC SPACE FROM LEFT TO RIGHT INTO THE ANTERIOR HALF OF THE DISC.. THE PATIENT TOLERATED THE PROCEDURE WELL..¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247726 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