BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM

    MDR report key: 3012094 · Received March 20, 2013

    Report

    Report Number
    8030965-2013-10546
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 17, 2012
    Report Date
    February 17, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    OVE
    PMA / PMN Number
    K073541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. IMPLANT DATE IS (B)(6) 2012, NOT EXPLANT DATE. ORIGINAL AWARENESS DATE IS (B)(4) 2012. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT STATUS POST ZERO P PROCEDURE LEVEL C3-4, UNKNOWN DATE OF IMPLANTATION, CLP-VA PLATE AND SCREW PROCEDURE LEVEL C5-7, UNKNOWN DATE OF IMPLANTATION, RETURNED TO DIFFERENT SURGEON. IT WAS DETERMINED THE PATIENT HAD ADJACENT LEVEL DISEASE. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2012. THE ZERO-P HARDWARE AT C3-4 WAS LEFT INTACT, THE CLP-VA HARDWARE PLATE AND SCREW AT C5-7 WAS REMOVED, ALTHOUGH FUSION WAS ACHIEVED, THE HARDWARE WOULD INTERFERE WITH ADJACENT LEVEL HARDWARE TO IMPLANT. ALL SCREWS WITHIN THE CLP-VA PLATE WERE INTACT. AN ACDF WAS PERFORMED AT LEVEL C4-5 FOR THE ADJACENT LEVEL DISEASE. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    AS THE SURGEON INSERTED ONE OF THE LOCKING SCREWS, HE NOTICED A SMALL METAL SHAVING OR PEELED SCREW THREAD FRAGMENT COMING OFF THE LOCKING SCREW. THE SURGEON REMOVED THE METAL FRAGMENT, AND CONFIRMED BY MICROSCOPIC EXAMINATION THAT THE ENTIRE FRAGMENT WAS RETRIEVED. THE LOCKING SCREW REMAINED IN PLACE AND WAS SEATED COMPLETELY. THE SURGEON COMPLETED THE ACDF PROCEDURE WITH NO FURTHER PROBLEM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115773 3.0MM TI CERVICAL SPINE LOCKING SCREW 16MM OVE SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR