BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PLATE 5 HOLES 72MM

    MDR report key: 6877467 · Received September 19, 2017

    Report

    Report Number
    3003506883-2017-10206
    Event Type
    Injury
    Date Received
    September 19, 2017
    Report Date
    August 29, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    UDI-DI
    10886982157898
    PMA / PMN Number
    K082807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS (B)(6) CENTIMETERS. ADDITIONAL PATIENT IDENTIFIER: (B)(6). DATE PATIENT PAIN BEGAN IS NOT KNOWN. ADDITIONAL PRODUCT CODES: HWC, KTT. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW FOR PART # 223.551 LOT # 7241154. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 3.5MM LCP PLATE 5 HOLES 72MM PRODUCT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK NOR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 04 FEBRUARY 2013. MANUFACTURING SITE: (B)(6). 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 REQUESTED THAT ALL HIS HARDWARE BE REMOVED DUE TO PAIN. THE ORIGINAL IMPLANT DATE WAS (B)(6) 2016 FOR A LEFT RADIUS AND ULNA FRACTURES AND A LEFT FEMUR FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT. ALL THE BONES WERE HEALED AND THE HARDWARE WAS REMOVED FULLY INTACT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS STABLE FOLLOWING SURGERY. THIS REPORT IS FOR ONE (1) 3.5MM LCP PLATE. THIS IS REPORT 3 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655558 3.5MM LCP PLATE 5 HOLES 72MM PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 223.551 7241154 10886982157898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention