BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT BALL TIP PROBE

    MDR report key: 3022268 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-10438
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 1, 2012
    Report Date
    February 2, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE PART WAS RETURNED WITH A 25MM PORTION OF THE TIP BROKEN OFF. THE BROKEN TIP PORTION WAS ALSO BENT. BASED ON THE EVALUATION AND THE UNKNOWN ROOT CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN L5-S1 FUSION, THE PROBE SNAPPED OFF WHILE THE SURGEON WAS PROBING THE PEDICLE. THE BROKEN FRAGMENT WAS RETRIEVED. THE SURGEON USED ANOTHER PROBE TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS, AND THERE WAS NO HARM TO PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124180 STRAIGHT BALL TIP PROBE HSB SYNTHES MONUMENT 552590D05

    Patients

    Seq Age Sex Outcome Treatment
    1