BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI MATRIX REDUCTION SCREW 45MM THREAD LENGTH

    MDR report key: 6570338 · Received May 16, 2017

    Report

    Report Number
    2530088-2017-10112
    Event Type
    Malfunction
    Date Received
    May 16, 2017
    Date of Event
    April 13, 2017
    Report Date
    April 20, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    UDI-DI
    07611819345126
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. ADDITIONAL DEVICE PRODUCT CODES: MNH, MNI, KWQ, KWP. DEVICE BROKE INTRA-OPERATIVELY AND WAS NOT FULLY IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER PHONE NUMBER: (B)(6). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART: 04.634.645 / LOT: 9891005: MANUFACTURING SITE: (B)(4), MANUFACTURING DATE: 28-AUG-2015: NO NON CONFORMANCE REPORTS (NCRS) OR SCRAP 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 ACTION. 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NO LONGER EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY PERFORMED ON (B)(6) 2017 TWO SCREW HEADS DETACHED FROM THE SCREW SHAFTS. SURGEON USED SPARE SCREWS TO COMPLETE THE PROCEDURE. THERE IS NO REPORT OF PATIENT'S INJURY OR SURGICAL PROLONGATION. THIS REPORT IS FOR ONE (1) 6.0MM TI MATRIX REDUCTION SCREW 45MM THREAD LENGTH. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350767 6.0MM TI MATRIX REDUCTION SCREW 45MM THREAD LENGTH ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB SYNTHES BRANDYWINE 9891005 07611819345126

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR