BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR 5.5MM LOCKING SCREWS

    MDR report key: 3051874 · Received April 11, 2013

    Report

    Report Number
    1719045-2013-10549
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    November 15, 2011
    Report Date
    November 15, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    HWB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 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. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED FOR EVALUATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REVISION PROCEDURE, THE TIP OF A SET SCREW EXTRACTOR FELL APART AND THE TIP BROKE OFF A CONICAL EXTRACTING SCREW. THIS IS REPORT 2 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE YEARS AGO, PATIENT WAS IMPLANTED WITH A CLICK-X PEDICLE SCREW AT L3 TO L5. PATIENT DEVELOPED ADJACENT LEVEL DISC DISEASE AND ON (B)(6) 2011, THE CLICK-X HARDWARE WAS EXPLANTED AND THE FUSION WAS EXTENDED TO ADJACENT LEVELS: L2 TO S1 USING MATRIX HARDWARE. DURING THE REVISION PROCEDURE, THE TIP OF A SET SCREW EXTRACTOR FELL APART. WHILE SURGEON WAS INSERTING THE PEDICLE SCREW, A THORACIC PEDICLE PROBE BENT. A PALM RATCHET HANDLE WAS STICKING AND WILL NOT RATCHET. THE TIP BROKE OFF A CONICAL EXTRACTING SCREW. WHILE REMOVING SCREWS, THE TIP OF A 3.5MM HEXAGONAL SCREWDRIVER BECAME TWISTED. PATIENT IS (B)(6) MALE. THIS IS REPORT 16 OF 16 FOR THIS COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156629 CONICAL EXTRACTION SCREW FOR 5.5MM LOCKING SCREWS HWB SYNTHES (USA) MONUMENT 37455

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR