SYNTHES USA 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
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Catalog Number 04.647.836 |
Device Problems
Device Operates Differently Than Expected (2913); Difficult to Advance (2920)
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Patient Problem
Sedation (2368)
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Event Date 03/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This device was used for treatment, not diagnosis.No patient information has been provided.(b)(4).(b)(6).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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Event Description
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It was reported that during an anterior cervical discectomy and fusion (acdf) procedure at levels c5 to c7, the recess in the head of the screw was too shallow.While using the star drive t8 driver to insert the screws, the star drive t8 driver actually sheared off and burred out of the head of the screw making the screw impossible to insert and/or remove.As a result, the screws could not be locked in fully and could not be advanced.As an alternative, the surgeon used angled drivers rather than straight drivers to complete the procedure but those devices broke.The procedure was delayed by 45 minutes due to this incident.The screws have been implanted in the patient.No pieces from the instrument were left in situ.The patient had suboptimal results for this procedure; there was no harm to the patient reported.This report 1 of 7 for (b)(4).
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Manufacturer Narrative
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The complainant part has not been explanted.Without a valid lot number, a review of the device history records cannot be requested.The reported event has been determined to represent a product problem only.As such, no patient harm has been assessed for reporting.Device 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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