InjuryKWR
M2A CUSTOM TOTAL SCAPULA CONSTRAINING RING
Received Jan 10, 2007 · Event occurred Dec 12, 2006
Report 1825034-2007-00009 · MDR key 804896
Device
Product problems
- Replace
- Other (for use when an appropriate device code cannot be identified)
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING TOTAL SCAPULAR REPLACEMENT PROCEDURE IN 2006 CONSTRAINING RING COMPONENT WOULD NOT ASSEMBLE PROPERLY. AFTER ONE HOUR AND REPEATED ATTEMPTS TO ASSEMBLE, RING COMPONENT BECAME DEFORMED AND ALTERNATE PRODUCTS WERE USED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. EVALUATION OF RETURNED DEVICE FOUND INTERFERENCE EXISTED BETWEEN THE TWO COMPONENTS RESULTING IN PROBLEM REPORTED.