BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM

    MDR report key: 2842735 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03313
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    PMA / PMN Number
    K031276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. BOTH BROKEN SCREWS OF THIS COMPLAINT WITH UNKNOWN LOT NUMBERS WERE RECEIVED IN THE SAME PACKAGE. THERE ARE SEVERAL BROKEN OFF SCREW FRAGMENTS WHICH CANNOT BE ASSIGNED TO WHICH SCREW THEY BELONG. THE BIGGER PARTS ARE ALSO DAMAGED, DEFORMED AND SHOW MARKS OF A FORCEPS OR SIMILAR INSTRUMENT. DUE TO THE DAMAGE AND UNKNOWN LOT NUMBERS WE ARE NOT ABLE TO CHECK THE DIMENSIONS AND MANUFACTURING PROCEDURES.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. BASED ON THE INFORMATION PROVIDED, IT WILL NOT BE POSSIBLE TO DETERMINE WHAT THE CAUSE OF THE MALFUNCTION WAS. THE BREAKAGE LIKELY HAPPENED BEFORE THE PATIENT FUSED, BUT THERE IS NOTHING THAT INDICATES THE DESIGN CONTRIBUTED TO IT. THERE MAY HAVE BEEN SOME EXCESSIVE STRAIN BY THE PATIENT OR OTHER EXCESSIVE FORCES ON THE CONSTRUCT. THE DESIGN RISK ASSESSMENT IS ADEQUATE FOR THE INTENDED USE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH TI CERVICAL SPINE LOCKING PLATE AND SCREWS TO THE CERVICAL SPINE AT C4-C7 ON (B)(6) 2010. THE PATIENT RETURNED FOR A ROUTINE FOLLOW-UP AND X-RAYS WERE TAKEN. THE SURGEON NOTICED TWO OF THE CSLP SCREWS WERE BROKEN. REPORTEDLY ONE SCREW WAS BROKEN MID SHAFT AND THE OTHER SCREW WAS BROKEN A FEW THREADS BELOW THE HEAD OF THE SCREW. THE SURGEON DECIDED TO REMOVE ALL OF THE HARDWARE. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF ONE PLATE AND SIXTEEN SCREWS. PATIENT WAS NOT REVISED WITH ANY ADDITIONAL HARDWARE AS THE PATIENT WAS FUSED AND THE SURGEON WAS SATISFIED WITH THE OUTCOME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM SCREW KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention PLATE, SCREWS