BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM

    MDR report key: 3162064 · Received June 11, 2013

    Report

    Report Number
    2530088-2013-00906
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    October 26, 2011
    Report Date
    November 10, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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)(6). THE PRESENT PEDICLE SCREW WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AND DHR WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. A FUNCTION TEST WAS PERFORMED AND THE PEDICLE SCREW DID WORK AS REQUIRED. BASE ON THESE FINDINGS, WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DO TO ANY MANUFACTURING NON-CONFORMANCES. BASED ON THE COMPLAINT DESCRIPTION WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A L5-S1 FUSION USING A MATRIX SYSTEM THE SURGEON WAS PROGRESSING ONE OF THE SACRAL SCREWS IN FURTHER WITH A SOLID T-HANDLE SCREWDRIVER. DURING THIS, THE HEAD OF THE MATRIX SCREW DISCONNECTED ITSELF FROM THE PEDICLE SCREW. THE SCREW WAS REMOVED AND REPLACED WITH A LONGER 7MM SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263115 PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM NKB SYNTHES BRANDYWINE 6639760

    Patients

    Seq Age Sex Outcome Treatment
    1