BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW

    MDR report key: 2972375 · Received February 15, 2013

    Report

    Report Number
    1719045-2013-10021
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    FSM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 02/2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. BASED ON THE EVALUATION PERFORMED, AND THE UNK ROOT CAUSE, THIS COMPLAINT IS DEEMED INDETERMINATE FROM A MANUFACTURING POSITION. SCREW WAS RECEIVED BROKEN AND REMAINED IN THE CANCELLOUS EXPANSION HEAD SCREW. IT WAS IMPOSSIBLE TO DETERMINE IF THE TIP OR THE HEAD OF THE SCREW ARE ACCORDING TO THE SPECIFICATION. THE FRACTURE FACE IS HOMOGENOUS WHICH INDICATES MATERIAL CONFORMITY. THERE ARE ON ONE SIDE STRESS MARKS AT THE WINGS OF THE SCREW VISIBLE, THIS LET SYNTHES SUPPOSE THAT TOO MUCH LATERAL STRESS WAS APPLIED DURING THE REMOVAL OF THE SCREW. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS COULD NOT BE COMPLETED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) 2 LEVEL PROCEDURE THE SURGEON WAS INSERTING A 4.35MM TI CANCELLOUS EXPANSION HEAD SCREW AND HE INSERTED THE SCREW TOO FAR, SPLAYING THE HEAD OF THE SCREW. THE SURGEON THEN USED THE CONICAL EXTRACTION SCREW TO REMOVE THE SPLAYED SCREW AND THE VERY TIP BROKE OFF IN THE SPLAYED SCREW HEAD. THE SURGEON DID NOT REMOVE THE EXTRACTION SCREW AND THE CANCELLOUS SCREW, SELECTED ANOTHER SCREW AND COMPLETED THE PROCEDURE. THERE WAS NO ADDED TIME TO THE PROCEDURE. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69522 CONICAL EXTRACTION SCREW FSM SYNTHES (USA) A6I2161

    Patients

    Seq Age Sex Outcome Treatment
    1