BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM TI CANN MATRIX POLYAXIALSCREW 45MM THREAD LENGTH

    MDR report key: 3083305 · Received April 29, 2013

    Report

    Report Number
    2530088-2013-10519
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    October 26, 2011
    Report Date
    October 26, 2011
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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.

    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 DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED FOR A PRODUCT DEVELOPMENT EVALUATION AND THE SCREW WAS IN GOOD CONDITION. THE POLYAXIAL HEAD AND COLLAR WERE ATTACHED AND IN THE CORRECT POSITION. THE RETURNED DEVICE DID NOT MATCH THE COMPLAINT CONDITION. THE ONLY EVIDENCE OF USE WAS SOME VERY MINOR SCRATCHES IN THE BLUE ANODIZE OF THE STARDRIVE RECESS. THIS COMPLAINT IS INVALID FROM A DESIGN STANDPOINT. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LUMBER FUSION FROM L4-L5, THE SURGEON WAS INSERTING THE POLYAXIAL SCREW AND THE HEAD BROKE OFF. THE SURGEON USED A BACKUP SCREW. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184050 6.0MM TI CANN MATRIX POLYAXIALSCREW 45MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6738108

    Patients

    Seq Age Sex Outcome Treatment
    1