Spine revision was performed on (b)(6) 2014 by dr (b)(6).
Revision was performed due to subsidence of the bengal cage.
Also, it was reported that a concomitant device skyline plate and four concomitant device skyline variable screws had moved due to patient's anatomy and were removed and replaced during the revision.
However, these variable screws are intended to move/toggle to allow loading of the graft.
If the graft subsides the screws will not and are not intended to provide further resistance to motion.
The screws and the plate did not cause or contribute to the event.
Implantation date is not known.
The devices were discarded.
Patient outcome: patient appears to have irreversible c7 quadriplegia.
Post-operative mri was performed and rep was informed that the quadriplegia was due to query devascularisation.
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Concomitant products: depuy synthes spine does not use therapy dates as required as the implant date is unknown, the date of this report has been entered into the required field.
A complaint investigation will be performed.
The complaint product is not available for the investigation.
A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.
Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Discarded by customer.
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