BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4163622 · Received October 10, 2014

    Report

    Report Number
    1030489-2014-03998
    Event Type
    Injury
    Date Received
    October 10, 2014
    Report Date
    March 7, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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)(6). (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 ON (B)(6) 2005 THE PATIENT UNDERWENT A T6 TO T3 POSTERIOR SPINAL FUSION USING RHBMP-2/ACS. IT WAS REPORTED THAT ON (B)(6) 2005 THE PATIENT UNDERWENT AN ANTERIOR INTERBODY FUSION FROM T12 TO L2 SPINAL FUSION SURGERY FOR BURST FRACTURE WITH ASSOCIATED VERTEBRAL OSTEOMYELITIS WITH CANAL COMPROMISE AND WITH RADICULAR SYMPTOMS. IT WAS REPORTED THAT ON (B)(6) 2007 THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION OF T6-T7, T9-T10 AND L2-L3 AND AUGMENTATION OF BONE GRAFTING IN THE REST OF THE FUSION MASS USING RHBMP-2/ACS. IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT UNDERWENT AN EXPLORATION OF FUSION FROM T6 TO L3 WITH AUGMENTATION OF FUSION MASS WITH INFUSE AND VITOSS BONE GRAFT SUBSTITUTE AND BONE MARROW ASPIRATION FROM THE RIGHT ILIAC CREST USING RHBMP-2/ACS. IT WAS REPORTED THAT ON (B)(6) 2010 THE PATIENT UNDERWENT A POSTEROLATERAL FUSION, L4-L5 USING RHBMP-2/ACS. IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT SURGERY FOR AN INFECTED HUMERAL ALLOGRAFT STATUS POST ANTERIOR POSTERIOR RECONSTRUCTION FOR L1 BURST FRACTURE. IT WAS REPORTED THAT IMAGING STUDIES SHOWED THAT THE PATIENT HAD DEVELOPED UNCONTROLLED BONE GROWTH AND RESULTING NERVE COMPRESSION AT OR NEAR THE IMPLANT SITE. IT WAS REPORTED THAT THE PATIENT NOW EXPERIENCES SEVERE INJURIES AND DAMAGES, INCLUDING BUT NOT LIMITED TO CHRONIC PAIN, RADICULITIS, EMOTIONAL DISTRESS, AND MENTAL ANGUISH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2005 THE PATIENT UNDERWENT THE FOLLOWING SURGERIES: POSTERIOR SPINAL FUSION; INSTRUMENTATION USING TITANIUM LEGACY FROM T6 TO L3; AUTOGENOUS LOCAL BONE GRAFTING, AUGMENTED WITH RHBMP-2/ACS AND DEMINERALIZED BONE MATRIX IN THE FORM OF OSTEOFIL TO TREAT THE FOLLOWING PRE-OP DIAGNOSIS: BURST FRACTURE L1 WITH VERTEBRAL OSTEOMYELITIS. OP-NOTES: ¿..THEN WE WENT AHEAD AND PACKED ALL DECORTICATED FACET JOINTS WITH RHBMP-2/ACS AND AUTOGENOUS BONE AND ALSO IN THE INTERLAMINAR SPACE. THE PATIENT TOLERATED THE PROCEDURE WELL..¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640243 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 Required Intervention