MalfunctionHAW
DISPOSABLE REFLECTIVE MARKER SPHERES
Received Aug 19, 2015
Report 3002743211-2015-00048 · MDR key 5015615
Device
Product problems
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE NOT RETURNED.
Description of Event or Problem
CUSTOMER (OR MANAGER, (B)(6)) INFORMED US THAT THEY HAD ONE ISSUE OF A SPHERE FALLING APART WHILE ATTEMPTING TO THREAD IT ONTO A POST. CUSTOMER CANNOT RECALL WHEN THE INCIDENT OCCURED, DID NOT RECORD LOT NUMBER OR ANY OTHER INFORMATION.