Catalog Number 03.802.019 |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/21/2012 |
Event Type
malfunction
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Event Description
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A complaint was received from a consultant in regards to an alif stating; as the surgeon was using the synfix(tm)-lr trial impl 12de, the tip broke off, leaving the trial spacer in the intervertebral space.The surgeon was able to remove the trial spacer from the patient.The tip is still in the trial spacer.Surgery was completed without further incident and no adverse effect to the patient was noted.This is report 1 of 1 for complaint #(b)(4).
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Manufacturer Narrative
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Synthes is submitting this report as a result of remediation activities.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Device was used for treatment, not diagnosis.Manufacturing records were reviewed and no complaint related issues were found.Placeholder.
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Search Alerts/Recalls
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