BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI LOCKING SCR SELF-TAPNG WITH STARDRIVE RECESS 20MM

    MDR report key: 4242699 · Received November 11, 2014

    Report

    Report Number
    2520274-2014-14638
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    PK103243
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; AN INVESTIGATION OF THE RETURNED PRODUCTS CONFIRMED THAT THE SCREW HEADS BROKE OFF AND REMAINED IN THE LOCKING COMPRESSION PLATE (LCP). INVESTIGATION ON DOCUMENTATION FOR MATERIAL AND MANUFACTURING HAS BEEN CONDUCTED FOR LCP IMPLANT IN REFERENCE TO AVAILABLE LOT NUMBER. IT SHOWS THAT THE DEVICE HAS BEEN PRODUCED UNDER SPECIFICATION. NO FAILURE IN MATERIAL OR MANUFACTURING COULD BE DETECTED. FOR ALL RETURNED AND LISTED SCREWS A LOT NUMBER IS NOT KNOWN AND THEREFORE INVESTIGATION ON DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. ESPECIALLY THE THREE RETURNED CORTEX SCREW WITH STARDRIVE ARE OUT OF SCOPE FOR THE REPORTED EVENT. THESE DEVICES WERE INVOLVED IN IMPLANTATION AND EXPLANTATION BUT NOT RELATED TO THE REPORTED EVENT BECAUSE THEY ARE WITHOUT VISIBLE DAMAGES. IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THE BROKEN HEADS OF THE LOCKING SCREWS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR A UNKNOWN LOT NUMBER. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 WITHIN ONE MONTH AND A HALF AFTER SURGERY, SCREWS BROKE. SCREW HEADS WERE FIXED IN THE PLATE WHILE THE SHAFT OF SCREWS WERE BROKEN, IMPLANT WAS REMOVED FROM PATIENT. THIS REPORT IS 3 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725422 2.4MM TI LOCKING SCR SELF-TAPNG WITH STARDRIVE RECESS 20MM PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention