MalfunctionEZX
MICRO/MESH, 60 X 60 X .1MM
Received Jan 13, 1998
Report 8010177-1997-00082 · MDR key 144846
Device
Product problems
- Tears, rips, holes in device, device material
Patient
NA
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE DISTRIBUTOR RECEIVED AN INQUIRY FROM A DR REGARDING MICRO TITANIUM MESH. THE DR FELT THAT THE MESH WAS NOT UNIFIED IN HARDNESS. THE DISTRIBUTOR CHECKED THEIR INVENTORY AND NOTICED A DIFFERENCE IN SHAPE AND DIMENSION OF THE PLATE HOLES AND INDICATED THAT THE RETURNED MESH FROM THE HOSP WAS SOFTER. THIS EVENT IS NOT ASSOCIATED WITH A SURGICAL PROCEDURE.
Additional Manufacturer Narrative
SUMMARY OF EVALUATION: EVALUATION RESULTS AS RECEIVED FROM HOWMEDICA LEIBINGER GMBH IN FREIBURG, GERMANY REVEALED THE PRODUCT WAS OUT OF SPEC.
Remedial action
- Other