BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH

    MDR report key: 3062299 · Received April 16, 2013

    Report

    Report Number
    2530088-2013-10421
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    September 19, 2011
    Report Date
    September 19, 2011
    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. PRODUCT DEVELOPMENT EVENT EVALUATION REVEALS THE PARTS WERE RECEIVED. 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. MATRIX IS A MODULAR DESIGN AND THE HEAD IS DESIGNED TO BE CAPABLE OF BEING REMOVED FROM THE BONE SCREW IN CASE OF DAMAGE OR CHANGE IN SURGICAL PREFERENCE. IF THE HEAD IS REMOVED DURING SURGERY A NEW HEAD OR DIFFERENT STYLE HEAD CAN BE REPLACED WITHOUT THE NEED TO REPLACE THE BONE SCREW. A TOOL IS PROVIDED IN THE SET TO REMOVE HEADS FROM BONE SCREWS WITHOUT DAMAGING THE BONE SCREW. THE PARTS WERE REVIEWED AND MET THE DESIGN INTENT AND WERE REASSEMBLED AND HELD AS DESIGNED. SINCE THE HEAD IS REMOVABLE AND THE RETURNED PARTS MET THE DESIGN REQUIREMENTS WHEN REASSEMBLED, THIS COMPLAINT IS CONSIDERED INVALID. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF)PROCEDURE AT LEVELS L5-S1 , THE HEADS POPPED OFF THE POLYAXIAL SCREWS DURING INSERTION. THE SURGEON REMOVED THE BONE SCREW, AND REINSERTED NEW POLYAXIAL SCREWS WITH NO FURTHER PROBLEM. THIS IS 2 OF 2 REPORTS FOR EVENT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163372 7.0MM TI MATRIX POLYAXIAL SCREW 50MM THREAD LENGTH NKB SYNTHES BRANDYWINE 6753212

    Patients

    Seq Age Sex Outcome Treatment
    1