BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM NARROW LCP® PLATE 11 HOLES/206MM

    MDR report key: 4997683 · Received August 12, 2015

    Report

    Report Number
    3003506883-2015-10124
    Event Type
    Injury
    Date Received
    August 12, 2015
    Report Date
    July 23, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK082807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INITIALS ARE (B)(6). ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HWC. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: DATE OF MANUFACTURE: MAY 8, 2015. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 9802156 OF 4.5MM NARROW LCP PLATE 11 HOLES/206MM WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCES NOTED. THIS 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. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD DETERMINED THE RAW MATERIAL LOT 7864880 WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCES NOTED. THIS 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A NONUNION OF A HUMERAL SHAFT FRACTURE WITH A BROKEN 4.5MM NARROW 11-HOLE LOCKING COMPRESSION PLATE (LCP). THE BROKEN PLATE AND INTACT SCREWS WERE SUCCESSFULLY REMOVED ON (B)(6) 2015. THE PATIENT WAS REVISED WITH A 4.5MM 11-HOLE BROAD LCP PLATE. THERE WAS NO SURGICAL DELAY REPORTED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530901 4.5MM NARROW LCP® PLATE 11 HOLES/206MM PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 9802156

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention