BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSE X25 INSERTER/TIGHTENER

    MDR report key: 8910142 · Received August 20, 2019

    Report

    Report Number
    1526439-2019-52003
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    August 5, 2019
    Report Date
    August 5, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    HWR
    UDI-DI
    10705034467634
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UDI: (B)(4). 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. DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. WITHOUT THE RETURN OF THE DEVICE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. SHOULD MORE INFORMATION AND/OR THE SAMPLE BE PROVIDED AT A LATER TIME, THIS COMPLAINT WILL BE REOPENED AND DEVICE EVALUATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). (B)(4). ADDITIONAL INFORMATION: D4.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION 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

    SCOLIOSIS CORRECTION: DR (B)(6), (B)(6) 2019. DURING FINAL TIGHTENING OF THE CONSTRACT, THE VERSE X25 INSERTER BURRED, IT HAPPENED 4 TIME DURING THIS SURGERY. NO 'AE' TO THE PATIENT. THIS COMPLAINT INVOLVES FOUR (4) DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704465 VERSE X25 INSERTER/TIGHTENER DRIVER, PROSTHESIS HWR MEDOS INTERNATIONAL SàRL CH 299704230 GM4815303 10705034467634

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR