BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZERO-P IMPLANT 8MM HEIGHT LORDOTIC/LARGE-STERILE

    MDR report key: 3222718 · Received July 12, 2013

    Report

    Report Number
    8030965-2013-04295
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ALL FOUR THREADED HOLES SHOW WEAR TO ANODIZED SURFACES. THE RIGHT MEDIAL HOLE IS NOT DISCERNIBLY DIFFERENT FROM THE OTHER THREE HOLES. THE PEEK SURFACES DISTAL TO THE RIGHT MEDIAL HOLE SHOW SIGNIFICANT DAMAGE. THE FRONT OF THE PLATE HAS A FEW SCRATCHES. THE REMAINDER OF THE IMPLANT IS IN GOOD CONDITION. THE ZERO-P CERVICAL SPINE SYSTEM INCLUDES A FAMILY OF 48 STAND-ALONE INTERBODY DEVICES. THESE IMPLANTS INCLUDE A ZERO PROFILE TITANIUM ALLOY PLATE AND A PEEK INTERBODY SPACER. PREPARING THE SCREW HOLES WITH THE APPROPRIATE TRAJECTORY IS CRITICAL TO LOCKING THE SCREWS TO THE PLATE. THE ASSOCIATED DRAWINGS WERE REVIEWED FOR THE INTERBODY IMPLANTS. THESE DOCUMENTS CALL OUT THE APPROPRIATE DIMENSIONS, MATERIAL, AND FINISHING PROCESSES FOR A SUCCESSFUL INTERBODY IMPLANT. THE DAMAGE TO THE PEEK SURFACES DISTAL TO THE RIGHT MEDIAL HOLE SUGGESTS THE TRAJECTORY OF THIS HOLE WAS NOT AXIAL TO THE HOLE IN THE PLATE. THIS CONDITION WOULD NOT ALLOW THE SCREW TO FULLY SEAT TO THE PLATE. THE ENGINEER SUCCESSFULLY STARTED A 12 MM SCREW IN EACH OF THE FOUR HOLES IN THE RETURNED PLATE. THE EVIDENCE OF THIS RETURN SUGGESTS AN INCORRECT TRAJECTORY CONTRIBUTED TO THIS COMPLAINT. THE TRAJECTORY OF THE HOLE CREATED IN THE ANATOMY IS CRITICAL TO LOCKING THE SCREWS TO THE PLATE. SINCE THE EVALUATOR SUCCESSFULLY STARTED A SCREW IN THE RIGHT MEDIAL HOLE IN THE PLATE, THE DISPOSITION OF THIS COMPLAINT FROM A DESIGN PERSPECTIVE IS INDETERMINATE.

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL FUSION AT C4-C5 USING A ZERO-P IMPLANT, THE RIGHT MEDIAL SCREW WOULD NOT LOCK TO THE IMPLANT PLATE, AND JUST SPUN AROUND. THE OTHER 3 SCREWS LOCKED TO THE IMPLANT PLATE PROPERLY. SURGEON THEN REMOVED ALL 4 SCREWS, AND THE IMPLANT PLATE. A NEW IDENTICAL PLATE WAS THEN IMPLANTED, THE 4 ORIGINAL SCREWS WERE REIMPLANTED, AND ALL OF THEM LOCKED TO THE IMPLANT PLATE. NO FURTHER ISSUES DURING THE SURGERY. THE SURGERY WAS EXTENDED BY APPROXIMATELY 1 HOUR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322457 ZERO-P IMPLANT 8MM HEIGHT LORDOTIC/LARGE-STERILE OVE SYNTHES GMBH 8419506

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention