BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 11740843 · Received April 28, 2021

    Report

    Report Number
    1526439-2021-00819
    Event Type
    Injury
    Date Received
    April 28, 2021
    Report Date
    April 1, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #(B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A J&J SALES REPRESENTATIVE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ZHANG H, ET AL. (2012), A CLINICAL STUDY OF INTERNAL FIXATION, DEBRIDEMENT, AND INTERBODY THORACIC FUSION TO TREAT THORACIC TUBERCULOSIS VIA POSTERIOR APPROACH ONLY, INTERNATIONAL ORTHOPEDICS (SICOT), VOLUME 36, PAGES 293-298, (CHINA). THIS RETROSPECTIVE STUDY EVALUATED THE CLINICAL EFFICACY AND FEASIBILITY OF ONE-STAGE POSTERIOR INTERNAL FIXATION, DEBRIDEMENT, AND INTERBODY THORACIC FUSION IN THE TREATMENT OF THORACIC TUBERCULOSIS. FROM FEBRUARY 2005 TO FEBRUARY 2009, 60 PATIENTS WITH MONOSEGMENTAL THORACIC TUBERCULOSIS WHO UNDERWENT ONE-STAGE INTERNAL FIXATION, DEBRIDEMENT, AND INTERBODY THORACIC FUSION TO TREAT THORACIC TB VIA A POSTERIOR APPROACH ONLY (POSTERIOR SPINAL FUSION) (PSF) GROUP WERE INCLUDED IN THE STUDY. ANOTHER 54 CASES WHO UNDERWENT ONE-STAGE OR PHASED DEBRIDEMENT AND INTERBODY THORACIC FUSION VIA THE POSTERIOR APPROACH AND INTERNAL FIXATION VIA THE ANTERIOR APPROACH TO TREAT THORACIC TB WERE THE CONTROL GROUP (COMBINED ANTERIOR/POSTERIOR SURGERY) (A-P) GROUP. THE FOLLOWING IS A DESCRIPTION OF A TYPICAL CASE IN THE PRACTICE. A (B)(6) YEAR-OLD MALE WAS ADMITTED FOR BACK PAIN AND BILATERAL LOWER EXTREMITY WEAKNESS. NEUROLOGICAL FUNCTION, ASIA GRADE C. T5¿6 INTERVERTEBRAL DAMAGE AS THE CENTER OF SINGLE-SEGMENT SPINAL TB, DISC COMPLETELY DESTROYED AND CORRESPONDING VERTEBRAL BODY DESTRUCTION; PERIPHERAL ABSCESS. THE PATIENT HAD LEFT SIDED, FOCAL CLEANING, INTERVERTEBRAL BONE GRAFTING WITH UNKNOWN DEPUY SPINE MOSS MIAMI SCREW-ROD SYSTEM AND ALLOGENIC HOMOGRAFT. POSTOPERATIVE SAGITTAL INDEX OF 0 DEGREES. BONE GRAFT FUSION AT 12 MONTHS. CORRECTION ANGLE LOSS OF 3 DEGREES. ASIA GRADE OF NERVE FUNCTION RECOVERED TO GRADE E. THIS REPORT IS FOR THE UNKNOWN DEPUY SPINE MOSS MIAMI SCREW-ROD SYSTEM. THIS REPORT IS FOR (1) UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES. THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637337 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention