Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems
Pain (1994); Neck Pain (2433)
Event Type
Injury
Event Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that there was right arm pain and posterior neck pain, with a start date of (b)(6) 2012 and end date of (b)(6) 2012.The event was possibly related to the type or surgery and possibly related to the implant.Treatment intervention was cervical spine epidural block.This report is for an unknown cervios.This is report number 1 of 1 for (b)(4).
Manufacturer Narrative
Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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.