BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM

    MDR report key: 15715981 · Received November 2, 2022

    Report

    Report Number
    1526439-2022-01902
    Event Type
    Injury
    Date Received
    November 2, 2022
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    UDI-DI
    10705034077437
    PMA / PMN Number
    K111136
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. ADDITIONAL NARRATIVE: DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PROCODE: ADDITIONAL DEVICE PRODUCT CODES: OSH, KNB, KWP, MNI, KWQ. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY FOR ROD BREAKAGE ON (B)(6)2020. AFTER THE REVISION SURGERY, THE ROD IN QUESTION WAS BROKEN. A SECOND REVISION SURGERY WAS PLANNED TO BE PERFORMED ON (B)(6) 2022. A CONNECTOR WAS PLANNED TO BE USED, AND THE ROD WAS NOT PLANNED TO BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM. THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE ROD BREAKAGE THAT OCCURRED AFTER THE PRIMARY SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2913174 EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH 179762480 10705034077437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention