BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4570013 · Received March 4, 2015

    Report

    Report Number
    1030489-2015-00411
    Event Type
    Injury
    Date Received
    March 4, 2015
    Report Date
    February 10, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PREOPERATIVE DIAGNOSES OF SEVERE DEGENERATIVE DISK DISEASE AND SPONDYLOLISTHESIS AT L4-L5 AND L5-S1, STATUS POST LUMBAR LAMINECTOMY WITH INTRACTABLE BACK AND LEG PAIN. PER THE MEDICAL RECORDS, THE PATIENT UNDERWENT TWO-LEVEL LUMBAR INTERBODY FUSION AT L4-L5 AND L5-S1 USING BONE MORPHOGENIC PROTEIN AND AUTOLOGOUS BONE AS WELL AS PEEK ROD COMPATIBLE SCREWS, WIDE REDO LUMBAR LAMINECTOMY AT L4-L5 AND L5-S1, NARROW AT L3-L4 WITH LATERAL MASS FUSION L4-S1, INTRAOPERATIVE CT SCAN WITH FRAMELESS STEREOTACTIC STEALTH NAVIGATION AND EMG NERVE MONITORING. PER OP NOTES, PREVIOUS SURGICAL INCISION WAS OPENED. TRANSVERSE PROCESSES WERE EXPOSED FOR THE LATERAL MASS FUSION THAT WAS DONE AT THE END OF THE CASE AFTER DECORTICATION AND USE OF BONE MORPHOGENIC PROTEIN AND AUTOLOGOUS BONE SAVED FROM THE SPINOUS PROCESS AND LAMINA. THERE WAS A VERY CAREFUL REDO LUMBAR LAMINECTOMY AT L3-L4 AND NARROWLY AT L4-L5 AND LS-51 WIDELY TO DECOMPRESS THE NERVE ROOTS AND THECAL SAC. THE DISK SPACES WERE EXPOSED AT L4-L5 AND LS-51 AND DISK MATERIAL REMOVED WITH A STRAIGHT AND ANGLED CASPAR PITUITARY RONGEURS. ROTATING CUTTERS USED TO REMOVE DISK MATERIA L. THE RASP USED TO DECORTICATE THE ENDPLATES AND PEEK INTERBODY CAGES PLACED UNDER CAREFUL EMG NERVE MONITORING, PROTECTING THE THECAL SAC WITH AN O'ERRICO NERVE ROOT RETRACTOR. LATERAL X-RAY SHOWED GOOD PLACEMENT OF THE SCREWS AND INTERBODY CAGES. PEEK RODS WERE SELECTED TO PLACE OVER THE SCREWS. SET SCREWS SECURED AND LOPPED OFF WITH COUNTER TORSION. NO PATIENT COMPLICATIONS WERE NOTED. POST-OP, THE PATIENT DEVELOPED UNSPECIFIED INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151396 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M110706AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other INTERBODY CAGES, AUTOGRAFT, RODS, SCREWS