BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RODS

    MDR report key: 9238159 · Received October 25, 2019

    Report

    Report Number
    1526439-2019-52281
    Event Type
    Injury
    Date Received
    October 25, 2019
    Report Date
    August 28, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 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: CASES OF SCREW FRACTURES. ONE ROD FRACTURES. SCREW PULLOUT. MOSS MIAMI PRODUCTS WERE USED AS A PART OF THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031555 UNKNOWN RODS UNKNOWN HSB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other