BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L40 T

    MDR report key: 3143559 · Received June 3, 2013

    Report

    Report Number
    2530088-2013-00859
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    March 22, 2011
    Report Date
    April 4, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K103287
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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.(B)(4)

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR VISUAL INSPECTION AND THE EVENT WAS CONFIRMED. A REVIEW OF THE DHR INDICATES THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. THE MANUFACTURING RECORDS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. ALL RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. WHILE, WE SUPPOSE THAT TOO HIGH A LATERAL STRESS HAS CAUSED THE OCCURRENCE, WE ARE UNABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON. PLEASE NOT THAT IN SUCH CIRCUMSTANCES IT IS RECOMMENDED WHEN THE PANGEA SCREWS ARE USED WITH SPIRIT, IT IS VITAL TO AVOID PUSHING FORWARD THE HOLDING SLEEVE WHILE INSERTING/ADVANCING THE SCREW INTO THE VERTEBRAE. THE SAME APPLIES WHEN ORIENTATING THE HOLDING SLEEVE CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. WHILE, WE SUPPOSE THAT TOO HIGH A LATERAL STRESS HAS CAUSED THE OCCURRENCE, WE ARE UNABLE TO GIVE A CONCLUSIVE STATEMENT REGARDING A POSSIBLE FAILURE REASON AND THE COMPLAINT CONDITION IS DUE TO AN UNKNOWN CAUSE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY THE GOLD PART OF THE SCREW BROKE UPON CONTACT WITH THE ROD. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244500 PEDICSCR PANGEAPOLYAX Ø6 PREASSMBL L40 T NKB SYNTHES BRANDYWINE 6554849

    Patients

    Seq Age Sex Outcome Treatment
    1