BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SCREWS

    MDR report key: 9331045 · Received November 15, 2019

    Report

    Report Number
    1526439-2019-52442
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Report Date
    October 18, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 510K: THIS REPORT IS FOR AN UNKNOWN SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HUAMING XUE, MD, YIHUI TU, MD, PHD, MINWEI CAI, MD THE SPINE JOURNAL 12 (2012) 209¿215 (CHINA): THE AIM OF THIS STUDY WAS TO COMPARE CLINICAL AND RADIOGRAPHIC OUTCOMES IN A SELECTED SERIES OF PATIENTS TREATED WITH UNILATERAL VERSUS BILATERAL PS INSTRUMENTED TLIF. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 3- SCREW LOOSENING WERE REPORTED AS A PART OF THIS STUDY. MOSS MIAMI PRODUCTS WERE USED AS A PART OF THIS STUDY. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS REPORT 3 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123670 UNKNOWN SCREWS SCREW, FIXATION, BONE HWC MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1