BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0MM NON-COLORED THREADED GUIDE WIRE-SPADE POINT 230MM

    MDR report key: 6403313 · Received March 14, 2017

    Report

    Report Number
    2520274-2017-10856
    Event Type
    Injury
    Date Received
    March 14, 2017
    Report Date
    February 15, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    LXT
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CODES: LRN, JDW. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, AS IT HAS BEEN REPORTEDLY DISCARDED BY THE FACILITY. (B)(4): TIP UNABLE TO BE RETRIEVED FROM THE CORTICES OF THE LEFT FEMUR. NO SERVICE HISTORY REVIEW CAN BE PERFORMED BECAUSE THE LOT/SERIAL NUMBER IS UNKNOWN AND CANNOT BE TRACED. THE MANUFACTURE DATE IS UNKNOWN. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    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

    THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5067234. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: SUPRACONDYLAR RIVAL ANGLE PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185554 2.0MM NON-COLORED THREADED GUIDE WIRE-SPADE POINT 230MM APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM LXT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1 QTY OF UNKNOWN SUPRACONDYLAR RIVAL ANGLE PLATE| UNKNOWN QUANTIY OF UNKNOWN SCREWS