BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM LCP PLATE 12 HOLES 163MM

    MDR report key: 4081919 · Received September 11, 2014

    Report

    Report Number
    3003506883-2014-10105
    Event Type
    Malfunction
    Date Received
    September 11, 2014
    Report Date
    August 15, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK082807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT 5863032 OF 3.5MM LCP PLATE ¿ 12 HOLES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES 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. 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 REDUCTION WRIST FUSION OF THE DISTAL RADIUS AND CARPUS WAS PERFORMED SIX YEARS AGO. THERE WAS A NON-UNION AND PLATE THAT BROKE EIGHT MONTHS AGO AND THE PATIENT WAS TREATED NON-OPERATIVELY WITH A CAST. THE BROKEN PLATE WAS REMOVED AND REVISED WITH A NEW LOCKING COMPRESSION WRIST FUSION PLATE. THE PATIENT EXPERIENCED PAIN, IRRITATION AND DISCOMFORT. IT WAS REPORTED THAT THE PATIENT WAS NON-COMPLIANT. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560703 3.5MM LCP PLATE 12 HOLES 163MM PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 5863032

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention