Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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This report is for four (4) unknown locking screws for synfix evolution.Part#, lot# and udi # is not available.Device product code xxx used for code ovd.Device is not explanted.Still in patient.Device is not expected to be returned for manufacturer review/investigation.This report is for four (4) unknown locking screws for synfix evolution.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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Event Description
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It was reported that the patient underwent an l3-4, l5-s1 anterior lumbar interbody fusion (alif) on (b)(6) 2016 with a synfix evolution implanted at both levels.There was no posterior instrumentation on the initial procedure.On an unknown date, the patient fell on her deck at home and the l3-4 synfix evolution migrated anteriorly.The device is still intact but now proud of the l3-4 disc space.The patient was brought back for a l3-4 posterior lateral fusion on (b)(6) 2016.Patient and surgery outcome were not reported.Concomitant devices reported: synfix evolution (part# unknown, lot# unknown, quantity 1).This report is for four (4) unknown locking screws for synfix evolution.This is report 2 of 2 for com-(b)(4).
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Manufacturer Narrative
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X-ray review results: the synfix plate does appear to be proud anteriorly at the l3/4 level form the x-ray images provided.Ap view also indicates the device at l3/4 is not truly mid-line.The use of these devices at two non-continuous levels are off label though.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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Reportedly there was three (3) hours surgical delay during surgery.
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Search Alerts/Recalls
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