BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3191868 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02566
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    December 5, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTEROLATERAL APPROACH L5-S1 FUSION USING RHBMP-2/ACS MIXED WITH HYDROXYAPATITE GRANULES. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH INJURIES, INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HERSURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON (B)(6) 2003, PATIENT UNDERWENT FOLLOWING PROCEDURE: POSTERIOR-LATERAL INTERTRANSVERSE PROCESS TECHNIQUE ARTHRODESIS L5-S1. PRE-OP DIAGNOSIS: LOWER BACK PAIN 2. RULE OUT L5-S1 PSEUDOARTHROSIS POST-OP DIAGNOSIS: PSEUDOARTHROSIS L5-S1 PER OPERATIVE NOTES: " THE L5-S1 FACET JOINTS WERE REMOVED IN OBLIQUE FASHION USING AN OSTEOTOME DOWN TO THE LEVELS OF THE BASE OF PEDICLES. ALL THESE BONY SURFACES EXHIBITED BLEEDING FOLLOWING DECORTICATION. THE BONE FUSION WAS DONE USING RHBMP-2/ACS. AN APPROPRIATE DOSE OF RHBMP-2 WAS APPLIED TO COLLAGEN SPONGE PROVIDED IN THE KIT. SYNTHETIC HYDROXYAPATITE GRANULES WERE APPLIED TO THE COLLAGEN SPONGE.. THE TWO SPONGES WERE PACKED IN POSTEROLATERAL GUTTERS BILATERALLY ACCORDING TO THE TECHNIQUE FOR USE OF RHBMP-2/ACS.. THE PATIENT TOLERATED THE PROCEDURE AND WAS TRANSPORTED TO THE RECOVERY ROOM IN STABLE CONDITION.."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290415 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 00055 YR Required Intervention