BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM

    MDR report key: 3191881 · Received June 27, 2013

    Report

    Report Number
    2530088-2013-00962
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    December 12, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE EXAMINATION OF THE RAW MATERIAL AND THE MANUFACTURER DOCUMENTS REVEALED THAT NO DEVIATIONS IN REGARD TO MATERIAL ANALYSIS, TENACITY, STRUCTURAL STABILITY AND MANUFACTURING COULD BE ESTABLISHED. THE MEASURABLE DIMENSIONS OF THE RETURNED PEDICLE SCREW WERE EXAMINED AS FAR AS POSSIBLE; THE PART CORRESPONDS TO THE DRAWINGS AND AO/ASIF SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE SCREW HEAD BROKE DURING SURGERY. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294802 PEDICSCR MATRIX 5.5 POLYAXIAL Ø7 PREASSM NKB SYNTHES BRANDYWINE 6647474

    Patients

    Seq Age Sex Outcome Treatment
    1