BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4140730 · Received October 3, 2014

    Report

    Report Number
    1030489-2014-03813
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR FUSION AT L5-S1 USING RHBMP-2/ACS. FOLLOWING THE SURGERY, THE PATIENT SUFFERED SIGNIFICANT PAIN IN THE AREA OF THE FUSION SURGERY AND EXTREMITIES. THE PATIENT UNDERWENT ADDITIONAL IMAGING THAT SHOWED THAT THE PATIENT HAD DEVELOPED BONEY OVERGROWTH. THE PATIENT HAS RECEIVED SIGNIFICANT MEDICAL TREATMENT TO CARE FOR THE INJURIES CAUSED BY THE ORIGINAL FUSION SURGERY. THE PATIENT HAS NEVER RECOVERED FROM HER SURGERY, AND SHE HAS DAILY, 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) 2009, THE PATIENT PRESENTED WITH FOLLOWING PRE-OP DIAGNOSES: LARGE HERNIATED DISC L5-S1 CENTERING TO THE LEFT. FOR WHICH, PATIENT UNDERWENT FOLLOWING PROCEDURES: BILATERAL FUSION L5-S1. POSTERIOR LUMBAR INTERBODY FUSION, L5-S1. DISCECTOMY, FORAMINOTOMY AND DECOMPRESSION, L5-S1. INSERTION OF PEEK CAGES WITH BMP. INTERNAL FIXATION USING INTERNAL FIXATION, LEGACY INTERNAL FIXATION SYSTEM. SPINE PLATE AUGMENTATION. AUTOGRAFT LAMINECTOMY. CONTINUOUS NEURO-ELECTROPHYSIOLOGICAL MONITORING. PER OP-NOTES, "BMP WITH GRAFT MATRIX WAS TAKEN AND PLACED IN THE INTERBODY. A 10X22 INTERBODY CAGE FILLED WITH BMP WAS INSERTED INTO THE INTERSPACE AND COUNTERSUNK. LOCAL BONE THAT HAS BEEN HARVESTED WAS TAKEN AND PLACED LATERALLY IN THE GUTTERS AS WELL AS BMP WITH GRAFT MATRIX. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620900 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