BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH

    MDR report key: 3072440 · Received April 23, 2013

    Report

    Report Number
    2530088-2013-10495
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 24, 2012
    Report Date
    March 24, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. AFTER REVIEWING THE DHR FOR ALL MATERIAL, COMPONENTS AND ASSEMBLIES, NO DISCREPANCIES WERE FOUND THAT COULD BE RELATED TO THE COMPLAINT CONDITION. THE PRODUCT EVALUATION VISUAL INSPECTION REVEALED THAT THE POLYAXIAL SCREW ASSEMBLY WAS RETURNED WITH THE BODY AND COLLET ASSEMBLED AND THE SCREW SEPARATED FROM THE ASSEMBLY. THE COLLET COMPONENT OF THE POLYAXIAL BODY ASSEMBLY SHOWS MINIMAL SIGNS OF WEAR FROM CONTACT WITH THE OUTSIDE OF THE SCREW HEAD FROM THE ASSEMBLED STATE. THERE IS NO VISUALLY OBVIOUS DAMAGE TO THE POLYAXIAL BODY. THE THREADS IN THE SCREW HEAD ARE NEARLY SHEARED OFF FROM ENGAGEMENT WITH A HOLDING SLEEVE. THE RETURNED PARTS WERE REASSEMBLED WITHOUT DIFFICULTY AND THE POLYAXIAL HEADS RETAINED SECURELY ON THE SCREWS AS DESIGNED AND COULD ONLY BE REMOVED WITH THE PROPER TOOL. THIS COMPLAINT WAS DEEMED INVALID FROM A DESIGN PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THORACOLUMBAR PROCEDURE AT T10-L3 THE SURGEON HAD TIGHTENED ALL THE LOCKING CAPS AND NEEDED TO LOOSEN THEM. DURING LOOSENING OF THE CAPS THE TIPS OF THE SCREWDRIVERS BENT. DURING THE PROCEDURE THE THREADS ON THE TIP OF THE HOLDING SLEEVE BROKE AND THE HEADS OF THE PREASSEMBLED PEDICLE SCREWS CAME OFF DURING INSERTION. TWO OTHER SCREWS WERE USED TO COMPLETE THE PROCEDURE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174283 8.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6857278

    Patients

    Seq Age Sex Outcome Treatment
    1