BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5MM TI CORTEX SCREW SELF-TAPPING 30MM

    MDR report key: 6582398 · Received May 22, 2017

    Report

    Report Number
    3009450884-2017-10068
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    March 18, 2017
    Report Date
    May 2, 2017
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    UDI-DI
    07611819201002
    PMA / PMN Number
    K112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODES: KTT, HRS. DATE OF IMPLANT IS NOT KNOWN. DEVICE IS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. HOSPITAL CONTACT TELEPHONE: (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE 414.830 - 9050690: NO NCRS 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. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 01.JUL.2014. 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 THREE (3) CORTEX SCREWS WERE BROKEN DURING PHYSIO ON (B)(6) 2017. IT IS NOT KNOWN IF A REVISION SURGERY WAS PERFORMED. THIS REPORT IS FOR ONE (1) CORTEX SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362508 4.5MM TI CORTEX SCREW SELF-TAPPING 30MM SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN 9050690 07611819201002

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR