BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREWS

    MDR report key: 9238001 · Received October 25, 2019

    Report

    Report Number
    1526439-2019-52278
    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

    (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 REVIEW OF THE FOLLOWING JOURNAL ARTICLE: VARUN CHANDRA, RAJ KUMAR SINGH, ANTERIOR LUMBAR INTER-BODY FUSION WITH INSTRUMENTATION COMPARED WITH POSTEROLATERAL FUSION FOR LOW GRADE ISTHMIC-PONDYLOLISTHESIS, ACTA ORTHOP. BELG., 2016, 82, 23-30 (INDIA). THE AIM OF THIS STUDY WAS TO COMPARE THE OUTCOME OF SURGICAL MANAGEMENT OF LOW GRADE SPONDYLOLISTHESIS WITH TWO TREATMENTS MODALITIES- POSTERO-LATERAL FUSION (PLF) AND ANTERIOR LUMBAR INTER-BODY FUSION (ALIF) WITH INSTRUMENTATION IN SIMILAR PATIENT PROFILE, OPERATED BY THE SAME SURGEON. THE OUTCOMES WERE COMPARED. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: CASE OF SCREW MIGRATION. SCREW FRACTURES. MOSS MIAMI PRODUCTS WERE USED AS A PART OF THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036725 UNKNOWN SCREWS UNKNOWN HWC MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other