Catalog Number 04.802.211 |
Device Problem
Unintended Movement (3026)
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Patient Problems
Unspecified Infection (1930); Non-union Bone Fracture (2369)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).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.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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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it is reported patient underwent an anterior lumbar interbody fusion (alif) and was implanted with an anterior tension band (atb) plate at l4-s1 and the synfix implants at l5-s1 on (b)(6) 2013.On unknown date it was determined patient had developed a non-union and an infection at the alif site, with two (2) sacral synfix screw had backed out of the synfix cage at l5-s1.Patient was returned to surgery on (b)(6) 2017 where all hardware was removed.Procedure went smoothly and patient outcome was reported as excellent.Swabs and tissue were sent to pathology.This report is 2 of 10 for (b)(4).
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Manufacturer Narrative
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A product investigation was completed: complaint is confirmed as we are able to confirm complaint description based on the received x-ray; a screw back-out could be verified from the provided x-ray.Product was not returned so no further investigation could be completed.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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Search Alerts/Recalls
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