BREMER 3D CROWN SYSTEM
Received Mar 16, 2011
Report 1526439-2011-00039 · MDR key 2023370
Device
Generic name
Skull Brace/hax
Manufacturer
Depuy Spine, Inc.Model number
NACatalog number
292301001
Lot number
J61007AR
Product problems
- Migration or Expulsion of Device
Patient
UNK
- Cerebrospinal Fluid Leakage
Narrative
Description of Event or Problem
ON (B)(6) 2010, THE 3D CROWN WAS FIXED TO THE PT. IN (B)(6) 2011, IT WAS FOUND THROUGH MRI THAT THE ANTERIOR PINS PENETRATED THE INNER TABLE OF SKULL. CEREBROSPINAL FLUID LEAKED FROM THE RIGHT FOREHEAD BONE. CRAMP OCCURRED AND THE LEVEL OF CONSCIOUSNESS WAS DECREASED. ALSO, PNEUMOCEPHALUS OCCURRED TOGETHER. THEN PT'S CONDITION WAS MONITORED. THE PT'S PREVIOUS DISEASE WAS RHEUMATISM. THE DOCTOR REQUESTED TO KNOW WHY 8 POUND TORQUE IS APPROPRIATE FOR THE FIXATION. AS AN ADVERSE OUTCOME WAS REPORTED, AN MDR IS FILED TO DOCUMENT THIS EVENT.
Additional Manufacturer Narrative
SKULL PIN PENETRATION IS A KNOWN POSSIBLE ADVERSE OUTCOME. PT HAD RHEUMATISM WHICH INDICATES THAT THE PT MAY HAVE COMPROMISED BONE QUALITY. AT THIS TIME, THE SPECIFIC PT INFO IS NOT KNOWN. PIN INSERTION SHOULD BE DONE UNDER FLUORO TO ENSURE PROPER PENETRATION. THEN THE PINS ARE RE-TIGHTENED 24-48 HOURS AFTER PLACEMENT AND THEN AS NEEDED. THE SYSTEM COMES WITH TORQUE LIMITING CAPS THAT BREAK AWAY AT 8 IN/LBS. FOR PTS WITH COMPROMISED BONE, THE USER SHOULD USE THE TORQUE PIN DRIVER THAT COMES IN THE PACKAGE. THE PIN DRIVER SHOULD ALSO BE USED WHEN RE-TIGHTENING TO 2-3 IN/LBS.