BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 13H/RIGHT/203MM

    MDR report key: 6894443 · Received September 26, 2017

    Report

    Report Number
    3003506883-2017-10216
    Event Type
    Injury
    Date Received
    September 26, 2017
    Report Date
    September 7, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    UDI-DI
    10886982034250
    PMA / PMN Number
    K083213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER UDI: (B)(4). DEVICE 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 USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HWC. IMPLANT DATE: THE ORIGINAL SURGERY TOOK PLACE APPROXIMATELY 5 MONTHS AGO. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. ADDITIONAL REPORTERS PHONE NUMBER: (B)(6). (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED: DATE OF MANUFACTURE (RELEASE TO WAREHOUSE DATE): 22 DECEMBER 2014. PLACE OF MANUFACTURE: SYNTHES USA- (B)(4). EXPIRATION DATE: 30 NOVEMBER 2024. LOT 7855050, PART NUMBER 02.112.156S, WORK ORDER (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 7855050, PART NUMBER 02.112.156S (DESCRIPTION: 2.7MM/ 3.5MM LCP LAT DISTAL FIBULA PLATE 13H/ RT/ 203MM-STERILE), WORK ORDER (B)(4) REVEALED ZERO MANUFACTURING/COMPLAINT RELATED ANOMALIES. THE DOCUMENTATION REVIEWED SHOWS THAT LOT 7855050 WAS PROCESSED THROUGH NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITHOUT ANY CONFIRMED NON-CONFORMANCE'S. THE DHR EVALUATION CONFIRMS THAT THE LOT MET ALL DOCUMENTATION, DIMENSIONAL, AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. SYNTHES LOT 7831717, PART NUMBER 49005 (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR RAW MATERIAL SYNTHES LOT 7831717, PART NUMBER 49005 (DESCRIPTION: (B)(4) FORGED RAW MATERIAL) REVEALED ZERO MANUFACTURING/COMPLAINT RELATED ANOMALIES. THE DHR EVALUATION CONFIRMS THAT THE LOT MET ALL DOCUMENTATION, DIMENSIONAL, AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 FIBULA HARDWARE REMOVAL WAS PERFORMED ON (B)(6) 2017 FOR THE REMOVAL OF THE 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 13H/RIGHT/203MM DEVICE DUE TO MALUNION AND DRAINING (POSSIBLE INFECTION). ALL OF THE HARDWARE WAS REMOVED. THE ORIGINAL SURGERY TOOK PLACE APPROXIMATELY 5 MONTHS AGO. THIS COMPLAINT HAS 4 DEVICE. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673828 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 13H/RIGHT/203MM PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 02.112.156 7855050 10886982034250

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention