BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

    MDR report key: 6846335 · Received September 6, 2017

    Report

    Report Number
    1719045-2017-10884
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 16, 2017
    Report Date
    August 16, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    DZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). 510K REPORTED AS: K083388. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: JEY. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY, THE SURGEON HAD IMPLANTED THE SCREW AND THE SCREW HEAD BROKE OFF AFTER IMPLANTATION. REMOVAL OF THE SAME WAS NOT DONE, PATIENT NOT HARMED. THE SURGERY WAS NOT EXTENDED BY ANY AMOUNT OF TIME. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    FURTHER IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ORBITAL FRACTURE FIXATION ON (B)(6), 2017. SURGEON REMOVED THE BROKEN FRAGMENT. SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626177 TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM SCREW FIXATION INTRAOSSEOUS DZL SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1