BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI MATRIX SCREW 45MM THREAD LENGTH

    MDR report key: 3033497 · Received April 3, 2013

    Report

    Report Number
    2530088-2013-00515
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SUNTHES USA
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES PART #04.639.745: THE HEAD OF THE 7.0MM TI MATRIX SCREW HAS A CRACKED THREAD WHERE IT INTERFACES WITH THE HOLDING SLEEVE. IT IS POSSIBLE THAT A BENDING LOAD WAS APPLIED BY THE SURGEON DURING THE BACKING OUT OF THE SCREW. THIS COULD HAVE LED TO TENSILE STRESSES CAUSING THE CRACK OF THE THREADED HEAD. IT IS UNKNOWN HOW THE SURGEON WAS BACKING OUT THE SCREW. IF A BENDING (LATERAL) FORCE WAS APPLIED, THE THREADED COULD HAVE CRACKED AS SEEN IN THIS COMPLAINT. PART #04.632.000: THE LOCKING CAP IS STUCK INSIDE THE PEDICLE SCREW WITH A PORTION OF THE ROD. IT IS NOT STATED WHETHER OR NOT THE TORQUE LIMITING HANDLE WAS USED FOR THE FINAL TIGHTENING. IF A GREATER TORQUE WAS APPLIED THAN 10 N-M, IT IS POSSIBLE THAT REMOVAL OF THE LOCKING CAP WILL BE DIFFICULT AS SEEN IN THIS COMPLAINT. IN ADDITION, IT IS NOT STATED WHETHER OR NOT THE 03.632.400 DRIVER WAS USED WITH THE TORQUE-LIMITING DRIVER TO ATTEMPT TO REMOVE THE LOCKING CAP. IT IS UNKNOWN WHETHER OR NOT THE TORQUE-LIMITING DRIVER WAS USED FOR FINAL TIGHTENING AND REMOVAL. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. SCREW WAS RECEIVED WITH NICKS AND SCRATCHES ON THE SD25 FACE AND VISUAL DISTORTION TO THE SD25 FORM. THE SCREW ALSO HAS APPROXIMATELY 60 PERCENT PEELED M6.5 X 0.75-6H THREAD. ALL DESCRIBED NONCONFORMITIES ARE POST MANUFACTURING. M6.5 X 0.75-6H THREAD COULD NOT BE MEASURED BECAUSE DAMAGE THAT WAS DOCUMENTED IN THE AS RECEIVED CONDITION. THE RAW MATERIAL WAS CHECKED WITH A NITON GUN AND PASSED SPECIFICATIONS. THE INVESTIGATION IS ONGOING. SHOULD BE SYNTHES USA: ENTERED IN ERROR. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. (B)(4).

    Description of Event or Problem · 1

    DURING L5-S1 LUMBAR FUSION PROCEDURE ON (B)(6) 2013, THE SURGEON WAS HALF WAY THROUGH PLACING A 7.0 MM TITANIUM MATRIX SCREW AT THE S1 LEVEL, A SMALL RING OF METAL AT THE TOP OF THE SCREW SNAPPED OFF, WHERE THE HOLDING SLEEVE CONTACTS THE SCREW. WHILE BACKING OUT THE SCREW, THE REPLACED SCREWDRIVER THREADS WERE DAMAGED. THE LOCKING HOLDING SLEEVE ALSO HAD THREADS DAMAGED AND WAS UNABLE TO BE USED. THE SURGEON USED ANOTHER SCREWDRIVER AND SUCCESSFULLY PLACED THE SCREW AT LEVEL S1. ONCE THE CONSTRUCT WAS FINISHED AND THE HEADS WERE PLACED INTO LOCKING CAPS AFTER FINAL TIGHTENING, THE SURGEON DECIDED TO REDIRECT ONE OF THE LOCKING CAPS. THE SURGEON WAS UNABLE TO REMOVE THE LOCKING CAP. WHILE TRYING TO REMOVE THE LOCKING CAP A STANDARD DRIVER AND A STARDRIVE SCREWDRIVER SHEARED OFF AND ANOTHER STARDRIVE SCREWDRIVER BECAME DEFORMED. THE SURGEON USED A METAL CUTTING BURR TO CUT THE ROD THAT STILL IS STUCK INSIDE THE HEAD OF THE SCREW AND USED A COUNTER TORQUE DEVICE TO REMOVE THE SCREW. ALL PARTS WERE RETRIEVED, THE PROCEDURE WAS DELAYED APPROXIMATELY ONE HOUR DUE TO THE EVENTS LISTED. THIS IS FOR A 7.0MM TI MATRIX SCREW 45MM THREAD LENGTH. THIS IS REPORT 5 OF 8 PARTS FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    THIS IS 5 OF 8 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135742 7.0MM TI MATRIX SCREW 45MM THREAD LENGTH NKB SUNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention