BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE

    MDR report key: 3192624 · Received June 27, 2013

    Report

    Report Number
    8030965-2013-04128
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K030069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A CRANIOSYNOSTOSIS PROCEDURE FOR TRIGONOCEPHALY, THREE 1.5MM RAPID RESORBABLE CORTEX SCREW (4MM STERILE) SCREW HEADS SNAPPED OFF AS THE SURGEON WAS ADVANCING A SCREW WITH A THUMB AND INDEX FINGER TURN INSERTION. THE SURGEON HAD USED A 1.1MM DRILL BIT, 4MM IN LENGTH AND TAP TO PREPARE THE SCREW HOLE. THE SURGEON DECIDED TO COMPLETE THE SURGERY WITH A COMPETITORS PRODUCT INSTEAD. IT WAS REPORTED THAT THE SURGERY WAS DELAYED 10 MINUTES. PATIENT WAS NOTED TO BE STABLE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294568 1.5MM RAPID RESORBABLE CORTEX SCREW 4MM-STERILE JEY SYNTHES GMBH 8186320

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR