BEUDAMED
    FDA Adverse Event Other Summary report: N

    DOC SYSTEM

    MDR report key: 298153 · Received September 27, 2000

    Report

    Report Number
    1526439-2000-00017
    Event Type
    Other
    Date Received
    September 27, 2000
    Report Date
    September 27, 2000
    Manufacturer
    DEPUTY ACROMED, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEPUY ACROMED WAS INFORMED THAT A PT WAS EXPERIENCING SYMPTOMS OF AN ALLERGIC REACTION. IT WAS DETERMINED THAT AN INFECTION HAD OCCURRED AND IT WAS DECIDED THAT THE CONSTRUCT NEEDED TO BE EXPLANTED. THE SURGEON REQUESTED THAT A MATERIAL COMPOSITION TEST BE CONDUCTED. CO IS CURRENTLY IN THE PROCESS OF CONDUCTING AN EVALUATION.

    Description of Event or Problem · 1

    DEPUY ACROMED WAS INFORMED THAT A PT WAS EXPERIENCING SYMPTOMS OF AN ALLERGIC REACTION. IT WAS DETERMINED THAT AN INFECTION HAD OCCURRED AND IT WAS DECIDED THAT THE CONSTRUCT NEEDED TO BE EXPLANTED. THE SURGEON REQUESTED THAT A MATERIAL COMPOSITION TEST BE CONDUCTED. THE DOC CONSTRUCT WAS ANALYZED FOR MATERIAL COMPOSITION. ALL COMPONENTS CONFORMED TO THE MATERIAL SPECIFICATIONS EXCEPT FOR THE NEEDLE SCREWS, WHERE THE ALUMINUM CONTENT WAS FOUND TO BE BELOW SPECIFICATIONS. DUE THE EXTREMELY SMALL SIZE OF THE NEEDLE SCREWS, ACCURATE READINGS ARE DIFFICULT TO ACHIEVE. HOWEVER, THIS CONDITION WOULD NOT HAVE A MATERIAL AFFECT ON THE DEVICE AND WILL NOT CONTRIBUTE TO THE ALLERGIC REACTION REPORTED IN THIS EVENT. COMPLAINTS CONCERNING ALLERGIC REACTIONS ARE USUALLY REPORTED FOR STAINLESS STEEL DEVICES AND ARE USUALLY ASSOCIATED WITH THE NICKEL CONTENT IN THE STAINLESS STEEL. THIS EVENT IS MOST LIKELY NOT DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOC SYSTEM DOC CONSTRUCT MCV DEPUTY ACROMED, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other