BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4208762 · Received October 29, 2014

    Report

    Report Number
    2520274-2014-14404
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    September 16, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR ONE SCREW, PART AND LOT NUMBER UNKNOWN THE PART NUMBERS FROM THE IMPLANT REPORT ARE DOCUMENTED BELOW. SYNTHES CANNOT IDENTIFY WHICH OF THE DEVICES ARE THE COMPLAINED DEVICE FOR THIS EVENT. IMPLANTED SCREWS: 414.840 (QUANTITY 5) 4.5MM TI CORTEX SCREW SELF-TAPPING 40MM, 414.844 (QUANTITY 2) 4.5MM TI CORTEX SCREW SELF-TAPPING 44MM, 414.846 (QUANTITY 1) 4.5MM TI CORTEX SCREW SELF-TAPPING 46MM, 414.860 (QUANTITY 1) 4.5MM TI CORTEX SCREW SELF-TAPPING 60MM, 414.854 (QUANTITY 1) 4.5MM TI CORTEX SCREW SELF-TAPPING 54MM, 412.214 (QUANTITY 1) 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 40MM. (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    INITIALLY REPORTED AS (B)(6) 2014; SHOULD BE (B)(6) 2014. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT POST-OPERATIVE A SYNTHES TITANIUM PLATE IMPLANTED IN (B)(6) 2013 BROKE, A SCREW BROKE AND ONE SCREW BACKED OUT. THE SURGEONS REPORTED THE BREAKAGE TO BE CAUSED BY FATIGUE DUE TO A NON-UNION. THIS PATIENT HAD PREVIOUSLY BEEN OPERATED ON FOR A FEMUR FRACTURE RECEIVED IN A MAJOR TRAFFIC ACCIDENT, THE TREATMENT OF COMPETITORS NAIL SURGERY ON (B)(6) 2012 ALSO FAILED DUE TO A NONUNION. THE IMPLANTED SYNTHES PLATE FROM (B)(6) 2013 WAS DISCOVERED TO BE BROKEN (B)(6) 2014. THE PATIENT WAS IMPLANTED AGAIN ON (B)(6) 2014 WITH NEW IMPLANT AND THE BROKEN HARDWARE IMPLANTED ON (B)(6) 2013 WAS REMOVED. THE PATIENT HAS BEEN REPORTED TO HAVE SUFFERED LIMB LOSS, LAMENESS AND PAIN WALKING. AN IMAGE READING OF THE X-RAYS WAS CONDUCTED BY A MEDICAL DIRECTOR FROM THIS MANUFACTURER AND REPORTED THE FOLLOWING: I REVIEWED THE COMPLAINT NARRATIVE IN THE DEVICE REPORT AND THE ACCOMPANYING X-RAY. I CAN CONFIRM THAT THERE IS PLATE BREAKAGE. THIS REPORT IS FOR THE ONE UNKNOWN BACKED OUT SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693110 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention