BEUDAMED
    FDA Adverse Event Other Summary report: N

    MOSS MIAMI SYSTEM

    MDR report key: 321402 · Received March 19, 2001

    Report

    Report Number
    1526439-2001-00006
    Event Type
    Other
    Date Received
    March 19, 2001
    Date of Event
    March 8, 2001
    Report Date
    March 12, 2001
    Manufacturer
    DEPUY ACROMED INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT A MOSS MIAMI POLYAXIAL SCREW BROKE POST-OPERATIVELY AT THE BASE OF THE SCREW HEAD. A REVISION SURGERY WAS REQUIRED IN 2001 TO REMOVE THE BROKEN SCREW AND REPLACE IT WITH ANOTHER SCREW. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PATIENT. A DIMENSIONAL ANALYSIS WAS PERFORMED, WHERE THE SCREW WAS NOT DAMAGED, AND THE SCREW CONFORMED TO SPECIFICATIONS. A FRACTURE ANALYSIS WAS PERFORMED ON THE SCREW USING A SCANNING ELECTRON MICROSCOPE. THE SEM REVEALED THAT THE SURFACE OF THE BREAK AT THE BASE OF THE SCREW HEAD WAS RELATIVELY SMOOTH. THIS IS DUE TO THE TWO PIECES RUBBING AGAINST EACH OTHER REPEATEDLY. HOWEVER, THE BREAK DOES INDICATE SOME GRAINY CHARACTERISTICS WHICH INDICATES THAT THIS MAY HAVE BEEN A FATIGUE FRACTURE. NO MATERIAL DEFECTS WERE OBSERVED DURING THE SEM ANALYSIS. A MATERIAL ASSESSMENT TEST WAS PERFORMED AND THE SCREW CONFORMED TO SPECIFICATIONS. THE MOST LIKELY CAUSE OF THE EVENT IS A FATIGUE. IF THE SCREW IS SUBJECTED TO REPEATED LOADING CYCLES (AS INDICATED BY THE SEM ANALYSIS), THE SCREW MAY BREAK. IF THE PT DOES NOT FOLLOW ACTIVITY RESTRICTIONS IN THE POST-OPERATIVE PROTOCOL, INCREASED LOADING MAY BE APPLIED TO THE SCREW, CAUSING IT TO BREAK. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY ACROMED THAT A MOSS MIAMI POLYAXIAL SCREW BROKE POST-OPERATIVELY AT THE BASE OF THE SCREW HEAD. A REVISION SURGERY WAS REQUIRED IN 2001 TO REMOVE THE BROKEN SCREW AND REPLACE IT WITH ANOTHER SCREW. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12129 MOSS MIAMI SYSTEM POLYAXIAL SCREW HWC DEPUY ACROMED INC. NA UW2AX4

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other