BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL

    MDR report key: 3760305 · Received April 19, 2014

    Report

    Report Number
    2520274-2014-10943
    Event Type
    Malfunction
    Date Received
    April 19, 2014
    Date of Event
    March 31, 2014
    Report Date
    March 31, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE OUTER SLEEVE FRACTURED DURING THE FINAL TIGHTENING OF THE NUTS. THERE WAS A READILY AVAILABLE DEVICE PRESENT TO COMPLETE FINAL TIGHTENING. THERE WAS NO PATIENT HARM REPORTED. THE DEVICE WILL NOT BE RETURNED. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239138 POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL MISC ORTHO SURGICAL INSTR LXH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1