| Product Name/Description |
Disposable Reflective Marker Spheres
Product Numbers:
41773G Disposable Reflective Marker Sphere (90 Pcs)
41774G Disposable Reflective Marker Sphere (270 Pcs)
41772G Disposable Reflective Marker Sphere (3 Pcs)
Lot Numbers:
1014213001, C103461502, C107761402, C100111501, C1034813001, C108341301, C101021502, C103881402, C108721402, C101161401, C104761402, C109051301, C101611502, C105541402, C109251402, C102311401, C106521402, C1098312001, C102481502, C106721301, C110411401 |
| Reason/Issue |
Some DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together. Separation may occur during installation of the spheres onto reference arrays or surgical tools (i.e., when threading them onto posts), or potentially after installation on tools that are impacted with high forces. Should such a DRMS separate during a surgical procedure, there is a possibility for:
- A portion of the sphere, its reflective coating and cured or uncured adhesive contacting patient tissues.
- Contamination of surgical trays, surgical drapes, surgical tools or physicians’ gloves due to contact with the separated component.
- Prolongation of surgery due to the need to replace the broken sphere.
The resulting separated sphere halves will not continue to be tracked by the Brainlab Image Guided Surgery system. The failure rate for the affected lots is less than 0.5% and there have been no reported negative effects on any patient associated with this issue. |