BREMER HALO 3D CROWN
Received May 25, 2010 · Event occurred May 12, 2010
Report 1526439-2010-00075 · MDR key 1699456
Device
Generic name
Cervical Brace
Manufacturer
Depuy Spine, Inc.Model number
NACatalog number
292301000
Lot number
060558
Product problems
- Other (for use when an appropriate device code cannot be identified)
Patient
UNK
- Skull Fracture
Narrative
Description of Event or Problem
CONTACT IN (B) (6) REPORTED THAT WHEN PLACING A HALO CROWN, ONE OF THE ANTERIOR SKULL PINS PENETRATED THE FRONTAL SINUS BY 1-2MM. ACCORDING TO THE DOCTOR, HE DID NOT FEEL TIGHTENING OF THE PINS DURING SURGERY. AFTER THE SURGERY, ONE OF THE PINS WAS REPLACED TO PREVENT THE PIN GOING ANY FURTHER IN. THE PATIENT'S BONE QUALITY IS POOR. AS AN ADVERSE EVENT OCCURRED AN MDR IS FILED TO DOCUMENT THIS EVENT.
Additional Manufacturer Narrative
PATIENT WAS REPORTED TO HAVE POOR BONE QUALITY. CONTACT IN (B) (6) CONFIRMED THAT THE SURGEON WAS USING THE RED TORQUE LIMITING CAPS TO TIGHTEN THE SKULL PINS. THE CAPS ARE DESIGNED TO BREAK AT 8 IN LBS. AS STATED IN THE SURGICAL TECHNIQUE / IFU PROVIDED WITH THE DEVICE, THE HALO IS INTENDED TO BE PLACED ON ADULTS WITH GOOD BONE QUALITY. IF THE PRODUCT IS USED ON PATIENT WITH COMPROMISED BONE, IT IS THE RESPONSIBILITY OF THE SURGEON TO REVIEW THE LITERATURE AND ENSURE THAT THE APPROPRIATE PIN TORQUE IS USED. FURTHER THE DOCUMENT STATES, TORQUE LIMITED CAPS ARE NOT FOR USE ON PEDIATRIC PATIENTS OR FOR PATIENTS WITH COMPROMISED BONE QUALITY.