BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 5506432 · Received March 17, 2016

    Report

    Report Number
    1030489-2016-00704
    Event Type
    Injury
    Date Received
    March 17, 2016
    Report Date
    March 15, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). MULTIPLE PRODUCTS USED IN THE EVENT. IT IS KNOWN WHICH PRODUCT CAUSED THE EVENT. PRODUCT ID: 2922245, LOT NUMBER: 51AU, QUANTITY: 1; PRODUCT ID: 2968045, LOT NUMBER: 49AM. QUANTITY: 1; PRODUCT ID: 2922255, LOT NUMBER: 06AS, QUANTITY: 1; PRODUCT ID: 2153116, LOT NUMBER: 75AC, QUANTITY: 1. X-RAY ANALYSIS: PATIENT PRESENTED WITH LIGAMENT DISEASE. SHE HAD AN EXTENSIVE FIXATION FOR L2-S1 INCLUDING MULTILEVEL OBLIQUE PLATE AND CAGES. PATIENT STILL HAD BACK PAIN AT TIME OF COMPLAINT. 2-3 MONTHS POST OP THERE IS NO PROBLEM IDENTIFIED WITH HARDWARE ON POST OP X-RAY. ROOT CAUSE SURGICAL TECHNIQUE / PATIENT FACTORS. PRODUCT WAS NOT 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: ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH RADICULOPATHY. MOTOR DEFICIT- L2 TO S1: 5(BOTH LEFT AND RIGHT). SENSORY DEFICIT- LEFT L4 AND L5: INCOMPLETE. PATIENT WAS DIAGNOSED WITH DISC HERNIATION AT L1-L2(PROTRUDED), L4-L5(PROTRUDED), L5-S1(PROTRUDED). DISC DEGENERATION AT L1-L2, L2-L3, L3-L4, L4-L5, L5-S1. MILTILEVEL DISCOPATHIES AT L5-S1. SPINAL STENOSIS AT L4-L5(CENTRAL). SPONDYLOLISTHESIS AT L4-L5(GRADE 1). PATIENT PRESENTED WITH THE HISTORY OF HYPERTENSION. IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, PATIENT COMPLAINED OF LEFT AND RIGHT SACROILIAC JOINT PAIN. AS PER THE DOCTOR, IT WAS RELATED TO THE FIXATION (STABLIZATION) SYSTEM AND THE PLATES RELATED TO PROBABLE STRESS FROM ANTERIOR/POSTERIOR CONSTRUCT. ON (B)(6) 2016: PATIENT PRESENTED FOR FOLLOW-UP. ON (B)(6) 2016: PATIENT PRESENTED WITH RIGHT AND LEFT SENSITIVE RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163210 UNK INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Other