BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT SMALL

    MDR report key: 17622954 · Received August 24, 2023

    Report

    Report Number
    MW5144931
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 19, 2023
    Manufacturer
    SOFAMOR DANEK- SOFA / MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HAD SPINAL SURGERY TO IMPLANT A SPACER ON (B)(6) 2023 TO RELIEVE PRESSURE BETWEEN L3-4. TWO DEVICES IMPLANTED IN SPINE LUMBAR. POST OP BACTERIAL INFECTION DIAGNOSED UPON ADMISSION TO HOSPITAL ON (B)(6) 2023. EXPERIENCED SEVERE PAIN AND SPASMS SINCE SURGERY AND MRI CONDUCTED ON (B)(6) 2023 AND READ ON (B)(6) 2023 FOUND "STATUS POST INTERBODY SPACER AT L3-4 WITH EDEMA IN THE DISC SPACE, ADJACENT VERTEBRAL BODIES, VENTRAL EPIDURAL SPACE AND PSOAS MUSCLE WITH APPARENT LEFT PSOAS ABSCESS. FINDINGS ARE CONCERNING FOR DISCITIS OSTEOMYELITIS." HOSPITALIZED FROM (B)(6) 2023. TREATED WITH BROAD SPECTRUM IV ANTIBIOTICS AND RELEASED WITH PICC LINE INSTALLED TO CONTINUE IV ANTIBIOTICS FOR 6-8 WEEKS. DUE TO LAB ERROR THE BACTERIA WAS NOT SPECIATED AND THERE WAS NO ORIGINAL SPECIMEN LEFT TO DO SO FROM BEFORE ANTIBIOTICS WERE ADMINISTERED IN THE HOSPITAL. TWO DEVICES IMPLANTED: 1. INFUSE BONE GRAFT SMALL MANUFACTURER: SOFAMOR DANEK SOFA; MODEL NUMBER: 7510200; LOT NUMBER: MGP7850AAA 2. CAGE 10X18X55-10DEG- MANUFACTURER: NUVASIVE - NUVA; MODEL NUMBER: 1181055P2 IMPLANTED BY: DR. (B)(6) NEUROSURGEON. (B)(6) IMPLANTED AT: (B)(6) HOSPITAL (B)(6) . "STATUS POST INTERBODY SPACER AT L3-4 WITH EDEMA IN THE DISC SPACE, ADJACENT VERTEBRAL BODIES, VENTRAL EPIDURAL SPACE AND PSOAS MUSCLE WITH APPARENT LEFT PSOAS ABSCESS. FINDINGS ARE CONCERNING FOR DISCITIS OSTEOMYELITIS." REF REPORT: MW5144932.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1434872 INFUSE BONE GRAFT SMALL FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK SOFAMOR DANEK- SOFA / MEDTRONIC SOFAMOR DANEK USA, INC. 7510200 MGP7850AAA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Life Threatening| H| R