BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 7914628 · Received September 27, 2018

    Report

    Report Number
    1526439-2018-50912
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    June 9, 2016
    Report Date
    August 29, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    UDI-DI
    (01)UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: EVALUATION OF SURGICAL STRATEGY OF CONVENTIONAL VS. PERCUTANEOUS ROBOT-ASSISTED SPINAL TRANS-PEDICULAR INSTRUMENTATION IN SPONDYLODISCITIS. NAUREEN KERIC1, DAVID J. EUM1,2, FEROZ AFGHANYAR1, IZABELA RACHWAL-CZYZEWICZ3,4, MIRJAM RENOVANZ1, JENS CONRAD1, DOMINIK M. A. WESP1, SVEN R. KANTELHARDT1, ALF GIESE1 J ROBOTIC SURG (2017) 11:17¿25. RECEIVED: 6 FEBRUARY 2016 / ACCEPTED: 26 APRIL 2016 / PUBLISHED ONLINE: 9 JUNE 2016. N=5 POST OP SCREW LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756754 UNKNOWN SCREWS UNKNOWN HWC MEDOS INTERNATIONAL SàRL CH (01)UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other