MalfunctionJDT
RADIUS LOCKING CAPS
Received Apr 17, 2007 · Event occurred Mar 23, 2007
Report 9617544-2007-00019 · MDR key 940429
Device
Generic name
Implant
Manufacturer
Stryker Spine BordeauxModel number
NACatalog number
486610000
Lot number
NA
Product problems
- Source, detachment from
Patient
YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, "T4-PELVIS HYBRID CONSTRUCT (90D+RADIUS). TOP CAP OF CONSTRUCT T4 POPED OFF. SEEN ON POST OP VISIT."
Additional Manufacturer Narrative
NO PRODUCT IS AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE SUPPLIED ON A SUPPLEMENTAL.
Remedial action
- Other