BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 7806684 · Received August 22, 2018

    Report

    Report Number
    1526439-2018-50815
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    January 1, 2017
    Report Date
    August 3, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    UDI-DI
    (01)UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS FILED AFTER SUBSEQUENT REVIEW OF LITERATURE ARTICLE: TRANSVERTEBRAL BONE GRAFT AND AUGMENTATION VERSUS POSTERIOR SPINAL INSTRUMENTATION IN THE TREATMENT OF SIMPLE THORACOLUMBAR COMPRESSION FRACTURES YANG HOU, JIANGANG SHI, JINGCHUAN SUN, YONGFEI GUO, GUOHUA XU, GUODONG SHI. RECEIVED 5 SEPTEMBER 2017; ACCEPTED 2 FEBRUARY 2018. N=1: SCREW LOOSENING POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647624 UNKNOWN SCREWS UNKNOWN HWC MEDOS INTERNATIONAL SàRL CH (01)UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other