BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 9238165 · Received October 25, 2019

    Report

    Report Number
    1526439-2019-52282
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    August 28, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). (01)UNAVAILABLE (11)UNKNOWN (10)UNKNOWN . 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: KIM H. , LEE C. , JEON B., PARK J., SAGITTAL PLANE ANALYSIS OF ADOLESCENT IDIOPATHIC SCOLIOSIS AFTER VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY) ANTERIOR INSTRUMENTATIONS. YONSEI MEDICAL JOURNAL. 2007 FEB 28; 48(1): 90¿96.(KOREA, SOUTH) THIS IS RETROSPECTIVE STUDY. TO REPORT, IN DETAILS ABOUT EFFECTS OF VATS ANTERIOR INSTRUMENTATION ON THE SAGITTAL PLANE. EVALUATIONS OF THE SURGICAL OUTCOME OF SCOLIOSIS HAVE PRIMARILY STUDIED IN CORONAL PLANE CORRECTION, FUNCTIONAL, AND COSMETIC ASPECTS. SAGITTAL BALANCE, AS WELL AS CORONAL BALANCE, IS IMPORTANT IN FUNCTIONAL SPINE. RECENTLY, SCOLIOSIS SURGERY APPLYING VATS HAS BEEN INCREASINGLY PERFORMED. ITS OUTCOME HAS BEEN REPORTED SEVERAL TIMES; HOWEVER, ACCORDING TO OUR SEARCH OF THE LITERATURE, THE ONLY ONE STUDY PARTIALLY MENTIONED. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 2 - CASES OF SCREW FRACTURES; 1 - ONE ROD FRACTURES; 1- SCREW PULLOUT. MOSS MIAMI PRODUCTS WERE USED AS A PART OF THIS STUDY. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031869 UNKNOWN SCREWS UNKNOWN HWC MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other