BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA BLOCKER

    MDR report key: 3010919 · Received March 19, 2013

    Report

    Report Number
    0009617544-2013-00084
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: COMPLAINT HISTORY, LABELING REVIEW. RESULTS: COMPLAINT HISTORY: GIVEN THE EVENT THAT WAS REPORTED, ONE WOULD CONSIDER THAT ISSUE COULD BE ASSOCIATED WITH POTENTIAL LOOSENING OF THE BLOCKER(S). HOWEVER, THE REVISION SURGERY THAT WAS CONDUCTED WAS SCHEDULED FOR L3 PSO AND THE POTENTIAL LOOSENING OF BLOCKERS WAS REPORTED DURING THIS REVISION. DATING BACK TO MARCH 2004, 43 COMPLAINTS WERE HIGHLIGHTED - MAKING THIS EVENT VERY UNLIKELY TO OCCUR GIVEN THE VOLUME OF BLOCKERS SOLD IN THAT TIME PERIOD. LABELING REVIEW: A REVIEW OF THE INSTRUCTION FOR USE OF THE XIA BLOCKER DEVICE NOTED THE FOLLOWING WARNINGS ASSOCIATED WITH RE USE AND INFORMATION FOR PATIENT: REUSE AN IMPLANT SHOULD NEVER BE REUSED. WHILE IT MAY APPEAR UNDAMAGED, A USED IMPLANT MAY HAVE ACQUIRED BLEMISHES OR LATENT COMPROMISE OF ITS INTEGRITY WHICH WOULD REDUCE ITS SERVICE LIFE. SURGEONS MUST VERIFY THAT THE INSTRUMENTS ARE IN GOOD CONDITION AND OPERATING ORDER PRIOR TO USE DURING SURGERY. ADDITIONALLY REVIEW OF IFU NOTED THE FOLLOWING APPLICABLE ADVERSE EFFECT WARNING RELATED TO THIS POTENTIAL FAILURE MODE: "LOOSENING OF SPINAL FIXATION IMPLANTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF THE PROSTHESIS OR TRAUMA. LATE LOOSENING MAY RESULT FROM TRAUMA, INFECTION, BIOLOGICAL COMPLICATIONS OR MECHANICAL PROBLEMS, WITH THE SUBSEQUENT POSSIBILITY OF BONE EROSION, MIGRATION AND /OR PAIN." CONCLUSION: NO INSPECTION OF THE PRODUCTS COULD BE PERFORMED AND EVENT AS REPORTED COULD NOT BE EVALUATED. INVESTIGATION WAS THEREFORE LIMITED. "LOOSENING OF SPINAL FIXATION IMPLANTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF THE PROSTHESIS OR TRAUMA. HENCE VARIOUS FACTORS CAN INFLUENCE THE POTENTIAL LOOSENING OF THE BLOCKERS SUCH AS IMPROPER INITIAL FINAL TIGHTENING, (OPTIMAL FINAL TIGHTENING TORQUE IS 12 NM PROVIDED BY THE TORQUE WRENCH AND USING THE ANTI-TORQUE KEY.), STABILITY OF THE INITIAL CONSTRUCT, ROD CONFIGURATION IN TULIP... IN THIS CASE, THE REVISION SURGERY WAS SCHEDULED IN ORDER TO PERFORM L3 PSO WHICH WAS NOT DONE DURING INITIAL SURGERY CONDUCTED (B)(6) 2012 WHERE S1-L4 WITH A ROD EXTENDING TO L2-3 CONSTRUCT WAS PUT IN PLACE. THIS SUPPORT THAT INSTABILITY OF THE CONSTRUCT WAS KNOWN. DURING REVISION SURGERY, ADDITIONAL SCREWS WERE ADDED AT L3 ALONG WITH ILIAC SCREWS. THE CONSTRUCT FROM ILIAC TO L2 WAS CONNECTED AND LOCKED DOWN WITH XIA BLOCKERS AND TORQUE. THE FACT THAT THE LOCKING CAPS WERE RE USED ALSO SUPPORTS THAT THERE WAS NOT SIGNIFICANT DEFORMATION OF BLOCKERS THAT COULD HAVE BEEN EXPECTED IF BLOCKERS WERE TIGHTENED AT THE RECOMMENDED TORQUE. THIS ALSO MAY SUPPORT IMPROPER FINAL TIGHTENING OR ROD CONFIGURATION ON THE CONSTRUCT. NOTE THAT IMPLANTS ARE NOT MEANT TO BE RE USED. DEVICE WAS RE-USED AND NOT RETURNED TO STRYKER.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO INSPECTION OF THE PRODUCTS COULD BE PERFORMED AND EVENT AS REPORTED COULD NOT BE EVALUATED. INVESTIGATION WAS THEREFORE LIMITED. "LOOSENING OF SPINAL FIXATION IMPLANTS CAN OCCUR. EARLY MECHANICAL LOOSENING MAY RESULT FROM INADEQUATE INITIAL FIXATION, LATENT INFECTION, PREMATURE LOADING OF THE PROSTHESIS OR TRAUMA." HENCE, VARIOUS FACTORS CAN INFLUENCE THE POTENTIAL LOOSENING OF THE BLOCKERS. IN THIS CASE, THE REVISION SURGERY WAS SCHEDULED IN ORDER TO PERFORM L3 PSO WHICH WAS NOT DONE DURING INITIAL SURGERY CONDUCTED (B)(6) 2012 WHERE S1-L4 WITH A ROD EXTENDING TO L2-3 CONSTRUCT WAS PUT IN PLACE. THIS SUPPORTS THAT INSTABILITY OF THE CONSTRUCT WAS KNOWN. DURING REVISION SURGERY, ADDITIONAL SCREWS WERE ADDED AT L3 ALONG WITH ILIAC SCREWS. THE CONSTRUCT FROM ILIAC TO L2 WAS CONNECTED AND LOCKED DOWN WITH XIA BLOCKERS AND TORQUE. THE FACT THAT THE LOCKING CAPS WERE RE USED ALSO SUPPORTS THAT THERE WAS NOT SIGNIFICANT DEFORMATION OF BLOCKERS THAT COULD HAVE BEEN EXPECTED IF BLOCKERS WERE TIGHTENED AT THE RECOMMENDED TORQUE. THIS ALSO MAY SUPPORT IMPROPER FINAL TIGHTENING OR ROD CONFIGURATION ON THE CONSTRUCT. NOTE THAT IMPLANTS ARE NOT MEANT TO BE RE USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "THE CASE WAS PLAN TO DO L3-4 PSO AND FUSION. THIS PATIENT HAD PREVIOUS STRYKER XIA AT S1-L4 WITH A ROD EXTENDING TO L2-3. NO SCREWS IN L3 IN FIRST SURGERY. UPON OPENING THE PATIENT AND DISSECTING DOWN TO THE SCREWS DR. (B)(6) NOTICED 2 SET SCREWS WERE OFF THE L2 SCREWS. XIA - ADDITIONAL SCREWS ADDED AT L3 ALONG WITH ILIAC SCREWS THE CONSTRUCT FROM ILIAC TO L2 WAS CONNECTED AND LOCKED DOWN WITH XIA BLOCKERS AND TORQUE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT .. "THE CASE WAS PLAN TO DO L3-4 PSO AND FUSION. THIS PATIENT HAD PREVIOUS STRYKER XIA AT S1-L4 WITH A ROD EXTENDING TO L2-3. NO SCREWS IN L3 IN FIRST SURGERY. UPON OPENING THE PATIENT AND DISSECTING DOWN TO THE SCREWS DR. POND NOTICED 2 SET SCREWS WERE OFF THE L2 SCREWS. XIA - ADDITIONAL SCREWS ADDED AT L3 ALONG WITH ILIAC SCREWS THE CONSTRUCT FROM ILIAC TO L2 WAS CONNECTED AND LOCKED DOWN WITH XIA BLOCKERS AND TORQUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114345 XIA BLOCKER IMPLANT KWP STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1