BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM TI CORTEX SCREW SELF-TAPPING 12MM

    MDR report key: 3897413 · Received June 26, 2014

    Report

    Report Number
    3009450884-2014-10026
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAMES: MQN, DZL. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD 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. 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 THE SURGEON HAD DIFFICULTY INSERTED ONE OF TWO SCREWS DURING IMPLANTING FOR A BORN FRACTURE. THE SECOND SCREW BROKE AT THE HEAD AND RESIDUE WAS LEFT IN THE PATIENT. NO SURGICAL DELAY WAS REPORTED THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374506 1.5MM TI CORTEX SCREW SELF-TAPPING 12MM SCREW,FIXATION,BONE HWC SYNTHES GRENCHEN 8784806

    Patients

    Seq Age Sex Outcome Treatment
    1