BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKSCR 3.5 SELF-TAP L10 TAN

    MDR report key: 3070331 · Received April 22, 2013

    Report

    Report Number
    2520274-2013-11104
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    October 24, 2011
    Report Date
    December 5, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 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. THIS IS REPORT 1 OF 1 FOR FILE (B)(4). ORIGINAL AWARENESS DATE IS (B)(6) 2011.

    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

    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. APPROXIMATE IMPLANT DATE WAS (B)(6) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 13 MONTHS AFTER THE OPERATION, WHEN THE DOCTOR TRIED TO REMOVE ALL 8 OF THE 3.5MM LOCKING SCREWS, ONE SCREW COULD NOT BE REMOVED FROM THE LOCKING COMPRESSION PLATE. SEVERAL TECHNIQUES WERE ATTEMPTED, BUT THE SCREW WOULD NOT COME OUT. THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172699 LOCKSCR 3.5 SELF-TAP L10 TAN KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention