WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
|
Back to Search Results |
|
Catalog Number 1556300500 |
Device Problem
Break (1069)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
Injury
|
Manufacturer Narrative
|
This part is not approved for use in the united states; however a like device catalog # 1556200500, 510k# k131321 and udi # (b)(4) was cleared in the united states.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Pre-operative diagnosis: scoliosis type of procedure used: olif (oblique lumbar interbody fusion) of 3 inter-vertebral discs, posterior tlif (transforaminal lumbar interbody fusion) at single level, psf (posterior spinal fusion) levels implanted: t9-s2ai it was reported that on unknown date, post-op, the implanted rods broke.Revision surgery was scheduled for removal.No other info was available.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Post-op, due to the breakage of the rod, on (b)(6) 2017, the broken part was reinforced with connector from another manufacturer.Post the second surgery, the rod broke again.A revision surgery has been scheduled to be performed again.
|
|
Search Alerts/Recalls
|
|
|