BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L45 T

    MDR report key: 3180637 · Received June 20, 2013

    Report

    Report Number
    2530088-2013-00969
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 8, 2012
    Report Date
    May 9, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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 INVESTIGATION HAS SHOWN THAT BY THE PRESENT PEDICLE SCREW PLANGEAPOLYAX, THE SCREW HEAD HAS FALLEN APART AS COMPLAINED. WE HAVE FORWARDED THE DEVICE IN QUESTION TO THE RESPONSIBLE PRODUCT DEVELOPMENT ENGINEER FOR EVALUATION. HE COULD NOT FIND THE EXACT CAUSE OF THIS PROBLEM. THEREFORE, WE DO HAVE TO ASSUME THAT THE PROBLEM OCCURRED DUE TO WRONG HANDLING DURING THE PROCEDURE. REVIEWING THE MANUFACTURING AND MATERIAL DOCUMENT SHOWS NO DEVIATION TO THE SPECIFICATION. NO PRODUCT FAULT COULD BE DETECTED.

    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. DEVICE MANUFACTURED ON 04/17/2011.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN LOADING THE SCREW TO THE SCREWDRIVER FROM THE RACK, WHERE IT WAS PLACED, IT WAS NOT POSSIBLE TO PLACE THE SCREWDRIVER INTO THE SCREW. IT WAS DISCOVERED THAT THE INNER PART OF THE SCREW WAS HALF WAY OUT OF THE OUTER PART. THAT LED TO A SEPARATION OF THE SCREW AND THE HEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281584 PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L45 T NKB SYNTHES BRANDYWINE 6648684

    Patients

    Seq Age Sex Outcome Treatment
    1