BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 6H/LT/137MM-XLNG

    MDR report key: 6416944 · Received March 20, 2017

    Report

    Report Number
    1000562954-2017-10030
    Event Type
    Injury
    Date Received
    March 20, 2017
    Report Date
    February 27, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    HRS
    UDI-DI
    10886982037268
    PMA / PMN Number
    K120070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ADDITIONAL DEVICE PRODUCT CODE HWC. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 02.117.706, LOT# 8013953. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: AUG 06, 2012. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH FOUR UNKNOWN SYNTHES 3.5 CORTEX SCREWS, EIGHT UNKNOWN 2.7 MM VAL SCREWS, SIX UNKNOWN 3.5 LOCKING SCREWS, A 7 HOLE 3.5 MM LCP POSTEROLATERAL DISTAL HUMERUS PLATE, AND A 6 HOLE EXTRA LONG 2.7/3.5 MM VA-LCP EXTENDED MEDIAL DISTAL HUMERUS PLATE TO TREAT A LEFT DISTAL HUMERUS FRACTURE ON AN UNKNOWN DATE. ON AN UNKNOWN DATE POSTOPERATIVELY, IT WAS IDENTIFIED THAT THE PATIENT HAD DEVELOPED A NON-UNION OF THE FRACTURE. ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND ALL OF THE DEVICES WERE REMOVED EASILY AND INTACT. THE NON-UNION WAS DEBRIDED AND GRAFTED AND THE PATIENT WAS REVISED WITH LONGER PLATES. NO DELAY IN SURGERY WAS REPORTED AND NO ADVERSE EVENTS AGAINST THE PATIENT WERE IDENTIFIED. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS REPORTED AS OKAY. THIS REPORT IS FOR ONE (1) 2.7 MM/3.5 MM VA-LCP EXT MEDL DSTL HUM PL 6H/LT/137 MM-XLNG. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201369 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 6H/LT/137MM-XLNG PLATE,FIXATION,BONE HRS SYNTHES MEZZOVICO 8013953 10886982037268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention