ALPHATEC SPINE, INC. ANTERIOR CERVICAL PLATE ASSEMBLY, 4-LEVEL, 064 MM (TI-6AI-4V ELI, NITINOL); SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
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Model Number 71004-064 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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No evaluation possible at this time.The implants have not been returned.Upon the receipt of additional information and/or the product in question, a follow-up report will be submitted.
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Event Description
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During a revision case, the surgeon placed all screws into plate.One of the screws went through the plate causing removal of the entire construct.The event caused the surgery to be delayed approximately 1.5 to 2 hours.
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Manufacturer Narrative
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Review of the device history records revealed no manufacturing, processing or design related irregularities.The trestle luxe plate was found to be properly manufactured and released in accordance with the device master record.Visual inspection found posterior damage to one of the thru holes where the screw passed completely thru the plate.Previous engineering investigation determined that this type of occurrence is the results of over angulation of the anchoring plate screw.Both the surgical technique (lit-84315) and instructions for use (ins-048) state; the surgeon must take great care to properly position bone screw holes when using the variable drill guide and self-centering awl.Excessively converging hole patterns may prohibit proper seating of the bone screws.Hole patterns angled beyond 9° may prohibit proper seating.
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