Additional patient id reported (b)(6).Patient weight is not available for reporting.Date of event is unknown.This report is for one (1) unknown screw.Part#, lot# and udi # is not available.Device was implanted in (b)(6) 2016.Exact date is unknown.Device is not expected to be returned for manufacturer review/investigation.Therapy date of each of the concomitant devices is unknown.This report is for one (1) unknown screw.Pma/510(k) number is not available.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that the surgeon performed a c1-t3 posterior cervical fusion on the patient in (b)(6) 2016 using synapse 3.5mm rod system including the following, (2) synapse 3.5mm shaft screws ¿ unknown length, (14) synapse screws ¿ unknown sizes, (16) synapse locking caps, and (2) 3.5 x 240mm rods.At an unknown point in time, the patient did not heal and has a nonunion.The left c1 synapse 3.5mm shaft screw (unknown length, and part and lot information is scratched ¿ cannot be read) broke at an unknown point in time.The surgeon also remarked that the c2 screws appear to be loosening in the bone and have lucencies on the ct scan.On (b)(6) 2016, the surgeon performed the revision.The surgeon then removed all the synapse hardware from the (b)(6) 2016 surgery.He could not get out the distal part of the left c1 screw that was broken.The surgeon replaced all the hardware with new synthes synapse 4.0mm rod system hardware.He did not replace the screws at c1 and c2.He did extend the construct up to the occiput with the synthes oc fusion set.He also used the synthes spine cable system to place c2 sublaminar wires that he ran to the rods.The surgeon then connected and tightened all the hardware and successfully completed the procedure.Patient outcome was reported as unknown.Concomitant parts reported: right-c1 synapse 3.5mm shaft screw, (part# unknown, lot# unknown, quantity1).C3 synapse screws (part# unknown, lot# unknown, quantity 12).Synapse locking caps (part# 04.614.508, lot # unknown, quantity 16).3.5mm ti rods-240mm (part# 498-957, lot# unknown, quantity 2).This report is for one (1) unknown screw.This is report 3 of 3 for (b)(4).
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