InjuryLYP
TSRH SPINAL SYSTEM
Received Jan 14, 1999 · Event occurred Dec 11, 1998
Report 1030489-1999-00005 · MDR key 206608
Device
Generic name
Spinal Fixation System
Manufacturer
Sofamor Danek ManufacturingModel number
NACatalog number
UNK
Lot number
UNK
Product problems
- Explanted
- Replace
- Material Separation
- Device Slipped
Patient
36 YR
- Surgical procedure, repeated
Narrative
Description of Event or Problem
IMPLANT DATE: 10/26/1998. X-RAYS REVEALED TSRH BOLT SLIPPED OFF END OF ROD ON THE RIGHT SIDE. REVISION SURGERY PERFORMED ON 12/11/1998 TO REMOVE AND REPLACE THE CONSTRUCT.