BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PLATE 5 HOLES 72MM

    MDR report key: 6877612 · Received September 19, 2017

    Report

    Report Number
    3003506883-2017-10207
    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

    (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 WAS COMPLETED. LOT 9931598, PART NUMBER 223.551. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 9931598, PART NUMBER 223.551 (DESCRIPTION: 3.5 MM LCP PLATE 5 HOLES 72 MM), REVEALED ZERO MANUFACTURING/COMPLAINT RELATED ANOMALIES. THE DOCUMENTATION REVIEWED SHOWS THAT LOT 9931598 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 7864850, PART NUMBER 17003. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR RAW MATERIAL SYNTHES LOT 7864850, PART NUMBER 17003 (DESCRIPTION: 316L**PI11.00X3.30 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. DATE OF MANUFACTURE (RELEASE TO WAREHOUSE DATE): 30 OCTOBER 2015. PLACE OF MANUFACTURE: SYNTHES USA- (B)(4). 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) 3.5 MM LCP PLATE. THIS IS REPORT 4 OF 11 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656727 3.5MM LCP PLATE 5 HOLES 72MM PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 223.551 9931598 10886982157898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention