BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3151180 · Received June 7, 2013

    Report

    Report Number
    8030965-2013-02828
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    July 4, 2012
    Report Date
    July 30, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. INVESTIGATION OF THE COMPLAINED DEVICE REVEALED THAT THE CONICAL ELEMENT INSIDE WAS TURNED OUT OF ITS ORIGINAL POSITION BY THE USER. FOLLOWING THE SURGICAL TECHNIQUE CAREFULLY WOULD PREVENT SUCH OCCURRENCES. NO PRODUCT FAULT COULD BE DETECTED. 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 CONCLUSION ¿ THE COMPLAINT IS CONSIDERED INDETERMINATE FROM A MANUFACTURING PERSPECTIVE. USER ERROR CONTRIBUTED TO THIS EVENT, AS THE CONICAL ELEMENT INSIDE WAS TURNED OUT OF ITS ORIGINAL POSITION BY THE USER.

    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. GENDER - FEMALE. AWARE DATE - (B)(6) 2012. THIS DEVICE IS SOLD IN THE U.S.; 510K # IS K100952. PLACEHOLDER.

    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.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON COULD NOT FIX THE SCREW IN L5. FIRST THE SURGEON INSERTED THE SCREWS, HOWEVER HE COULD NOT FIX THE SCREW IN L5 AS THE CONICAL ELEMENT OF THE PEDICLE SCREW WAS TURNED OUT OF ITS ORIGINAL POSITION. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253267 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM HWC SYNTHES GMBH 7556224

    Patients

    Seq Age Sex Outcome Treatment
    1