BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW SELF-DRILLING 4MM

    MDR report key: 6193085 · Received December 21, 2016

    Report

    Report Number
    1719045-2016-10936
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 29, 2016
    Report Date
    November 29, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    UDI-DI
    20887587018345
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE BROKE DURING INSERTION; DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). STERILE KIT PART 145.321S, LOT L092044: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: AUGUST 11, 2016. EXPIRY DATE: AUGUST 01, 2026. NON-STERILE SCREW PART 04.503.104.20, LOT H110805: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: MAY 24, 2016. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING IMPLANTATION THE HEAD OF A SCREW FROM A MATRIX NEURO STERILE KIT BROKE. THE SURGERY WAS NOT PROLONGED. THERE WAS NO PATIENT HARM AND ALL BROKEN OFF PIECES WERE REMOVED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842881 TI MATRIXNEURO SCREW SELF-DRILLING 4MM BONE PLATE JEY SYNTHES MONUMENT H110805 20887587018345

    Patients

    Seq Age Sex Outcome Treatment
    1