BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING CAP

    MDR report key: 2831988 · Received November 14, 2012

    Report

    Report Number
    2520274-2012-03143
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 18, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANT DATE REVISED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THE REPORTED DATE OF IMPLANT WAS APPROXIMATELY ONE YEAR AGO. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH HARDWARE ON AN UNKNOWN DATE APPROXIMATELY ONE YEAR AGO. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN TWO TO THREE MONTHS POST-OPERATIVELY. EXAMINATIONS REVEALED A BROKEN ROD, TWO BROKEN LOCKING CAPS AND ROD MIGRATION INTO SOFT TISSUE. REPORTEDLY THE PATIENT WILL REQUIRE EXTENSIVE AND LENGTHY REVISION SURGERY. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    INITIAL REPORT: PATIENT WAS IMPLANTED WITH HARDWARE ON AN UNKNOWN DATE APPROXIMATELY ONE YEAR AGO. IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN TWO TO THREE MONTHS POST-OPERATIVELY. EXAMINATIONS REVEALED A BROKEN ROD, TWO BROKEN LOCKING CAPS AND ROD MIGRATION INTO SOFT TISSUE. REPORTEDLY THE PATIENT WILL REQUIRE EXTENSIVE AND LENGTHY REVISION SURGERY. UPDATED REPORT: THE PATIENTS PAST MEDICAL HISTORY IS SIGNIFICANT FOR MULTIPLE, UNSPECIFIED BACK SURGERIES. THE MOST RECENT SURGERY ASSOCIATED WITH THIS REPORT OCCURRED IN (B)(6)2011. THREE POST OPERATIVE X-RAYS WERE TAKEN. THE FIRST WAS WITHIN NORMAL LIMITS. THE SECOND IN (B)(6) SHOWED THE ROD HAD SLIGHTLY MOVED. THE THIRD IN (B)(6) 2012 SHOWED THAT THE ROD HAD MOVED OUT FROM UNDER THE CAP, UPWARD INTO THE PATIENT'S SHOULDER MUSCLE, AND THE ROD WAS BROKEN. THE PATIENT HAD REVISION SURGERY IN (B)(6) 2012. REPORTEDLY, ALL HARDWARE WAS LEFT IN PLACE EXCEPT FOR THE BROKEN ROD, WHICH THE SURGEON CUT AT THE BREAK AND REMOVED THE TOP SECTION. THE LOOSE SCREWS IN THE CONSTRUCT WERE NOTED. THIS IS 1 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING CAP NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ROD, LOCKING CAP