BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3193261 · Received June 27, 2013

    Report

    Report Number
    2530088-2013-00988
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 17, 2012
    Report Date
    January 20, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    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. A REVIEW OF THE DHR FOR THIS LOT HAS BEEN REQUESTED. THE ADDITIONAL EVALUATION VISUAL INSPECTION REVEALED THAT THE COLLET IN THE SCREW HEAD IS BLOCKED AND ALSO SLIGHTLY OUT OF POSITION. THE OTHER THREAD OF THE SCREW IS ALSO DAMAGED. WE DO SUPPOSE THAT THE PEDICLE SCREW HAS NOT BEEN TIGHTENED UP ENOUGH OR THAT THE CONNECTION BETWEEN THE INNER AND OUTER HOUSING GOT LOOSE DUE TO HIGH FRICTION AND GOT LOOSE DURING USE. THIS IN COMBINATION WITH MECHANICAL FORCE DURING INSERTION CAN CAUSE SUCH OBSERVED DAMAGES. BASED ON THE EVALUATION, AND THE UNKNOWN CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION.

    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. ADDITIONAL INFORMATION: REVIEW OF THE DHR SHOWED THERE WERE NO ISSUES DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEAD POPPED OFF OF THE PART. THE SURGEON PLACED ALL OF THE SCREWS HALF WAY IN THE BONE WITH THE SCREWDRIVER AND SLEEVE, AND THEN TOOK AN X-RAY TO CHECK THE LENGTH AND DIRECTION OF THE SCREW. NO SCREWS NEEDED REPLACING. AFTER THAT, HE SCREWED ALL OF THE SCREWS AND IN THE END POSITION-USING THE SCREWDRIVER WITH NORMAL T-HANDLE WITHOUT SLEEVE AND RATCHET HANDLE. WHEN DOING THAT ON ONE OF THE SCREWS THE HEAD POPPED OFF WHEN THE SCREWHEAD CAME RIGHT CLOSE TO THE SURFACE OF THE BONE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294127 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES BRANDYWINE 6746468

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR