BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5903724 · Received August 25, 2016

    Report

    Report Number
    2520274-2016-14353
    Event Type
    Injury
    Date Received
    August 25, 2016
    Report Date
    August 22, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. THIS REPORT IS FOR ONE UNKNOWN 2.4MM VARIABLE ANGLE LOCKING SCREW WITH STARDRIVE RECESS. PART AND LOT NUMBERS WERE NOT AVAILABLE FOR REPORTING. OTHER NUMBER¿UDI: PART NUMBER UNKNOWN, UDI IS UNAVAILABLE. (THERAPY DATE): UNKNOWN. THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. THE COMPLAINT ISSUE WAS REPORTED TO A SYNTHES AFFILIATE BY AN UNKNOWN SURGEON. FACILITY INFORMATION IS ALSO UNAVAILABLE AT THIS TIME. (B)(4). THE 510(K): UNKNOWN. 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. DEVICE MANUFACTURE DATE: UNKNOWN. 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 EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN 2.4MM VARIABLE ANGLE LOCKING SCREW WITH STARDRIVE RECESS HAS BACKED OUT OF THE UNKNOWN PLATE. IN THE POSTOPERATIVE X-RAY THE SCREW WAS VIEWED AS BEING FLUSH WITH THE PLATE. IT IS UNKNOWN IF A TORQUE LIMITER WAS USED DURING THE SURGERY. IT IS UNKNOWN WHEN THE DEVICES WERE IMPLANTED AND WHEN THE REPORTED ISSUE WAS DISCOVERED. THIS REPORT IS FOR ONE UNKNOWN 2.4MM VARIABLE ANGLE LOCKING SCREW WITH STARDRIVE RECESS. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556380 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN PLATE