BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR 3.5 SELF-TAP L65 TI

    MDR report key: 3083396 · Received April 29, 2013

    Report

    Report Number
    8030965-2013-11195
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    November 29, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    K131186
    Product Problem
    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. 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. X-RAYS WERE RETURNED FOR EVALUATION AND IT WAS CONCLUDED THAT THIS INCIDENT HAPPENS FREQUENTLY IN YOUNG PATIENTS. IT WAS A REGULAR METAL ABLATION. THE BREAK OCCURRED DUE TO A STRONG MECHANICAL BURDEN. NO PRODUCT FAILURE COULD BE ASCERTAINED.

    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. ADDITIONAL INFORMATION: X-RAY IMAGES WERE TAKEN - EXACT DATE UNKNOWN. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HRS. ORIGINAL IMPLANT DATE UNKNOWN. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS THE DEVICE WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). (B)(4). INCORRECT 510K CHOSEN ON INITIAL SHOULD BE K131186.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING MATERIAL REMOVAL, ONE CORTEX SCREW HAD GROWN TOGETHER WITH THE BONE AND WAS NOT REMOVABLE. THE SCREW WAS BORED. THIS REPORT IS FOR FILE (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185068 CORTSCR 3.5 SELF-TAP L65 TI HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1