InjuryMBP
OPTIPLUG - UNK SIZE
Received Mar 12, 2014
Report 2090010-2014-00007 · MDR key 3687562
Device
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Osteolysis
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.
Description of Event or Problem
"A RECENT COMPLAINT CONCERNING SYNPLUG AND OSTEOLYSIS RESULTED IN A HEALTH HAZARD EVAL. THIS EVAL IDENTIFIED OSTEOLYSIS AS MEETING THE CRITERIA OF MDR REPORTABLE. A RETROSPECTIVE REVIEW HAS BEEN CONDUCTED OF OUR COMPLAINT MANAGEMENT SYSTEM RESULTING IN THE FILING OF THIS MDR".
Remedial action
- Notification