BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P VA IMPLANT 6MM HEIGHT LORDOTIC-STERILE

    MDR report key: 3192130 · Received June 27, 2013

    Report

    Report Number
    2520274-2013-03833
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS.THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.(B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DATE OF EVENT WAS REPORTED AS (B)(6) 2013. PRODUCT DEVELOPMENT EVALUATION EVENT, AS RECEIVED CONDITION, THE PLATE AND PEEK COMPONENTS OF THE IMPLANT WERE BOTH RECEIVED IN GOOD CONDITION. THERE IS A SMALL SCRATCH ON THE ANTERIOR OF THE PLATE NEAR THE "6" ETCH. ¿THIS COMPLAINT IS INDETERMINATE. AS A RESULT OF THE DESIGN, THE SPACER CAN DISSOCIATE FROM THE INTER-BODY PLATE IF IT IS MISHANDLED AND LOADS ARE APPLIED TO EACH PART IN OPPOSITE DIRECTIONS AND IN THE ORIENTATION OF THE KEYED INTERCONNECTION. THE IMPLANT IS MOST SUSCEPTIBLE TO THIS OCCURRENCE DURING IMPLANTATION IF UNEVEN INSERTION FORCES ARE APPLIED TO THE INTER-BODY PLATE AND SPACER. DISSOCIATION COULD ALSO HAPPEN IF THE HOLE PREP AND SCREW INSERTION INSTRUMENTS ARE USED OUTSIDE OF THE RECOMMENDED SCREW INSERTION ANGLE RANGES. THE RISK OF DISSOCIATION IN THE PATIENT POST-OP IS LOW BECAUSE THE INTER-BODY PLATE AND SPACER ARE LOADED IN THE SAME DIRECTIONS IN THE SPINE. THE IMPLANT DESIGN DOES ALLOW IT TO BE REASSEMBLED IF IT DISSOCIATES IF THE SURGEON CHOOSES TO DO SO, HOWEVER, THE MOST CONSERVATIVE SOLUTION IS TO USE A NEW IMPLANT AS DESCRIBED IN THE RISK ASSESSMENT.¿ MANUFACTURING EVALUATION, AS RECEIVED CONDITION, IMPLANT WAS RECEIVED DISASSEMBLED. NO VISIBLE DAMAGES AT THE TITANIUM- OR THE PEEK PART. A FUNCTION TEST WAS PERFORMED AND IT WAS POSSIBLE TO ASSEMBLE AND DISASSEMBLE THE PEEK PART FROM THE TITANIUM PART AS REQUIRED. ALSO THE PARTS HOLD TOGETHER WHEN THEY ARE ASSEMBLED AND CAN JUST WITH FORCE BE DISASSEMBLED AS REQUIRED. NO MANUFACTURING RELATED FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ZERO PROFILE SURGERY THE SURGEON USED SIZE SIX LORDOIC TRIAL AND DETERMINED IT TO BE AN APPROPRIATE FIT. THE SURGEON STARTED TO INSERT THE ZERO PROFILE IMPLANT WITH LIGHT PRESSURE. THE ZERO PROFILE IMPLANT CAME APART WITH THE METAL PLATE SEPARATING FROM THE PEEK IMPLANT. SURGEON RETRIEVED THE PRODUCT AND SELECTED ANOTHER ZERO PROFILE IMPLANT WHICH WAS INSERTED WITH NO FURTHER PROBLEMS. PROCEDURE WAS COMPLETED AND NO EXTRA TIME WAS NEEDED DURING SURGERY. THIS IS REPORT 1 OF 1 DEVICE FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292783 ZERO-P VA IMPLANT 6MM HEIGHT LORDOTIC-STERILE OVE OVE SYNTHES GMBH 8200516

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR