inforMED
MalfunctionDWZ

MDR event

Received Aug 17, 2005

Report 1418479-2005-00027 · MDR key 743174

Device

Product problems

  • Break
  • Device, or device fragments remain in patient
  • Material Separation

Patient

Not reported

  • Nonresorbable materials, unretrieved in body

Narrative

Additional Manufacturer Narrative

USER FACILITY WAS CONTACTED SEVERAL TIMES IN REGARDS TO PRODUCT EVAL AND NO RESPONSE. IF ADDITIONAL INFO IS AVAILABLE LATER IN TIME, A FOLLOW UP REPORT WILL BE SUBMITTED.