BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3083148 · Received April 29, 2013

    Report

    Report Number
    1030489-2013-01346
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    December 1, 2017
    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)(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

    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

    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 SUR GERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2005 ,PATIENT WAS ADMITTED TO THE FACILITY WHERE THE SURGEON PERFORMED SPINE FUSION SURGERY ON THE LUMBAR REGION OF HIS SPINE FROM VERTEBRAE L4 TO L5. POST-OP, PATIENT WAS REPORTED HAVING "WORSENING LOWER BACK PAIN, WITH PAIN RADIATING INTO BOTH LEGS". "SEVERE PAIN AND SYMPTOMS MAY RESULT IN PATIENT TO UNDERGO A REVISION SURGERY, WHICH HAS BEEN RECOMMENDED". PATIENT CONTINUES TO EXPERIENCE CHRONIC AND DAILY LOW BACK PAIN OF VARYING DEGREES, DEPENDING ON ACTIVITY LEVEL AND WEATHER". PATIENT USES CANE FOR AMBULATION AND TAKES PAIN MEDICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2005, THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SEGMENTAL INSTABILITY AND DISCOGENIC LOW BACK PAIN AT L4-5 AND UNDERWENT THE FOLLOWING PROCEDURES: POSTEROLATERAL INTERTRANSVERSE ARTHRODESIS, L4-L5, L5-S1. POSTERIOR LUMBAR INTERBODY ARTHRODESIS, L4-L5. PLACEMENT OF PROSTHETIC DEVICE, NUVASIVE PEEK INTERBODY CAGE, L4-L5. USE OF BONE MORPHOGENETIC PROTEIN. DECOMPRESSIVE LUMBAR LAMINECTOMY, L4-L5. BILATERAL L4 AND L5 FORAMINOTOMIES. MORCELLIZED ALLOGRAFT. EXPLORATION OF FUSION,L5-S1. REMOVAL OF POSTERIOR INSTRUMENTATION, L5-S1, WITH REO PEDICLE SCREW SYSTEM. PRE-OPERATIVELY, CT SCAN AND RADIOGRAPHIC STUDY REVEALED A SOLID INTERBODY FUSION AT L5-S1 LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185389 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other