BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBROPLASTY NEEDLE KIT 10G DIAMOND TIP

    MDR report key: 4222130 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14374
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Report Date
    August 28, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KIH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: FZX. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PHYSICIAN REPORTED A BROKEN NEEDLE. IT HAS BEEN REPORTED TO OCCUR BEFORE SURGERY. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704155 VERTEBROPLASTY NEEDLE KIT 10G DIAMOND TIP DISPENSER, CEMENT KIH SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1