BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR L LOCKING PLATE LUMBAR STAND ALONE

    MDR report key: 3716148 · Received April 1, 2014

    Report

    Report Number
    3005525032-2014-00045
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    OVD
    PMA / PMN Number
    K120869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL 6 ANCHOR L LOCKING PLATES THAT WERE IN THE SET WAS RETURNED BECAUSE THE SALES REP IS NOT SURE EXACTLY WHICH THREE OF THE 6 WERE USED IN THE SURGERY. CATALOG # 48667000. LOT/SERIAL NO. LBP; K34; JP8; JHS; KR6.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; DEVICE INSPECTION. RESULTS: THE RETURNED ANCHOR L LOCKING PLATE LUMBAR STAND ALONE WAS REPORTED TO NOT SECURELY ATTACH TO THE ANCHOR L CAGE UPON INSERTION LEADING TO A 5 MINUTE DELAY (S0). DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND NO MANUFACTURING ANOMALIES WERE REPORTED. FUNCTIONAL TESTING INDICATED THAT THE PLATE WAS WORKING PROPERLY. ACCORDING TO FOLLOW UP COMMUNICATION IT WAS REPORTED THAT THE SURGEON ATTACHED THE PLATE CORRECTLY TO THE CAGE, HOWEVER, THE PLATES WERE USED AND DEFORMED MULTIPLE TIMES. THE SURGICAL TECHNIQUE WARNS THAT REPETITIVE DEFORMATIONS MAY JEOPARDIZE THE INTEGRITY OF THE PLATE. NO ISSUES WERE FOUND WITH THE RETURNED PLATES AND THEREFORE THE LIKELY CAUSE OF THE REPORTED EVENT IS USER RELATED. CONCLUSION: THERE WERE NO ANOMALIES NOTED DURING A REVIEW OF THE MANUFACTURING RECORD, AND THE FUNCTIONAL TESTING INDICATED THAT THE PLATE WAS WORKING PROPERLY. NO ISSUES WERE FOUND WITH THE RETURNED PLATES AND THEREFORE THE LIKELY CAUSE OF THE REPORTED EVENT IS USER RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A L4-S1 ANTERIOR SPINAL FUSION CASE WITH ANCHOR L, THE SURGEON WAS UNABLE TO AFFIX A LOCKING PLATE TO THE SPACER AT THEL5/S1 AND L4/5 LEVEL. BOTH SPACERS WERE POSITIONED WITH THE SINGLE SCREW CEPHALAD AND 2 SCREWS CAUDAL. THREE OF OUR 6.0 X 25 WAS INSERTED INTO THE SPACER AT L4/5. THEY WERE INSERTED THROUGH THE APPROPRIATE DRILL GUIDE, KEEPING ATTENTION TO CONTINUE INSERTION UNTIL THE LASER LINE ON THE SCREWDRIVER WAS NO LONGER VISIBLE. AN X-RAY WAS TAKEN TO CONFIRM POSITIONING OF THE SCREWS. THE PLATE WOULD LOCK TO THE PEEK SPACER, BUT WOULD COME OFF WITH MINIMAL PULL STRENGTH FROM THE SURGEON. THEREFORE THE SURGEON ELECTED NOT TO USE THE LOCKING PLATE ON BOTH SPACERS AND FINISH THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A L4-S1 ANTERIOR SPINAL FUSION CASE WITH ANCHOR L, THE SURGEON WAS UNABLE TO AFFIX A LOCKING PLATE TO THE SPACER AT THE L5/S1 AND L4/5 LEVEL. BOTH SPACERS WERE POSITIONED WITH THE SINGLE SCREW CEPHALAD AND 2 SCREWS CAUDAL. THREE OF OUR 6.0 X 25 WAS INSERTED INTO THE SPACER AT L4/5. THEY WERE INSERTED THROUGH THE APPROPRIATE DRILL GUIDE, KEEPING ATTENTION TO CONTINUE INSERTION UNTIL THE LASER LINE ON THE SCREWDRIVER WAS NO LONGER VISIBLE. AN X-RAY WAS TAKEN TO CONFIRM POSITIONING OF THE SCREWS. THE PLATE WOULD LOCK TO THE PEEK SPACER, BUT WOULD COME OFF WITH MINIMAL PULL STRENGTH FROM THE SURGEON. THEREFORE THE SURGEON ELECTED NOT TO USE THE LOCKING PLATE ON BOTH SPACERS AND FINISH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196665 ANCHOR L LOCKING PLATE LUMBAR STAND ALONE IMPLATE-PLATE OVD STRYKER SPINE-SWITZERLAND KDV

    Patients

    Seq Age Sex Outcome Treatment
    1