BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES

    MDR report key: 8335360 · Received February 13, 2019

    Report

    Report Number
    8030965-2019-60958
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Report Date
    February 16, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819393967
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    Z-0669-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED IN A VETERINARY CASE - NO PATIENT INFORMATION WILL BE REPORTED. PART: 03.114.001; SYNTHES LOT: 9972971; SUPPLIER LOT: N/A; RELEASE TO WAREHOUSE DATE: MARCH 02, 2017; EXPIRATION DATE: N/A; SUPPLIER: (B)(4). APPROPRIATE ACTION HAS BEEN INITIATED ON JUNE 6, 2017 FOR LCP DRILL SLEEVE 03.114.001 DOES NOT ENGAGE WITH PLATE. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: VETERINARY COMPLAINT: IT WAS REPORTED THAT THE LOCKING PART OF THE DRILL SLEEVES DID NOT WORK. THE SURGEON NOTED THE ISSUE BEFORE THE SURGERY. THIS REPORT IS FOR A 1.1MM LCP THREADED DRILL GUIDE. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129994 1.1MM LCP THREADED DRILL GUIDE FOR 1.5MM LCP PLATES GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 9972971 07611819393967

    Patients

    Seq Age Sex Outcome Treatment
    1