Catalog Number 03.802.000 |
Device Problems
Fitting Problem (2183); Device-Device Incompatibility (2919)
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Patient Problem
Sedation (2368)
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Event Date 11/24/2014 |
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 that during the procedure, when putting the trial by using the handle for trial implant, straight.After insertion , the trial suddenly disengaged after certain times of impaction.The surgeon had failed to reengage manually because the locking of the trial handle is at the tip.However the locking knob was blocking by muscle and retractors as the procedure was alif.Finally, the surgeon had to remove more patient's bony structure to loosen the trapped trail.The sizer of synfix lr was cosmetically damaged as this was caused when removing the bony structure by blur.Removed bony structure , endplate of vertebra to enlarge the disc space for loosening the trial trapped.The case was prolonged 90 minutes because of this issue.This report is 1 of 2 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Without a lot number the device history record review and 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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No nonconformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.(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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Event Description
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Patient is reportedly good.
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Search Alerts/Recalls
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