Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.(b)(4).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 during spine surgery to treat degenerative disc disease at levels c5 ¿ c6 on (b)(6) 2017, as the surgeon trialed a 6mm lordotic anterior cervical fusion (acf) spacer, it plunged into the spinal cord resulting in paralysis.The trail spacer was not broken.The surgeon pulled the trial spacer out and waited to see if there was a recurrence of sensation.There was initial paralysis in the patient¿s arms and legs.The patient had regained movement in arms with limited sensation in hands.Paralysis continues in left leg.The surgery was completed with c5-6 acdf with vectra plate and (ccacf) corticocancellous anterior cervical fusion with lordotic tissue graft procedure.There was a reported 30-45 minute surgical delay.The surgery was completed.The patient condition had not improved in past six (6) days (after (b)(6) 2017).The current condition of the patient is not available for reporting.This report is 2 of 2 for (b)(4).
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