Catalog Number 03.812.509 |
Device Problem
Break (1069)
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Patient Problem
Sedation (2368)
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Event Date 08/01/2014 |
Event Type
Injury
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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 was reported the tip of the sleeve broke off in the handle and was stuck during surgery.The broken piece was able to be removed after the surgery was completed.The surgery was prolonged one hour.It was reported there was no serious injury to the patient due to this event.This is report 2 of 5 for com-(b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.(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.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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Manufacturer Narrative
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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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During a case on (b)(6) 2014, while using the transforminal posterior atraumatic lumbar cages the trial implant tip broke off completely and the travios implants were used which is what caused the delay to surgery.
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Search Alerts/Recalls
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