Catalog Number 48555422 |
Device Problems
Degraded (1153); Mechanical Problem (1384); Difficult to Remove (1528)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
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Event Date 06/16/2015 |
Event Type
malfunction
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Event Description
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It was reported that; removal at c3-t1.Removed blockers and rods with ease.Screw drivers stripped out while attempting to remove screws.Went through several drivers- each stripping out.Surgeon attached a small piece of rod and torqued down blocker to attempt to back out screw using the rod.The tulip popped off on 3 out of the 6 screws he used this method.Surgeon drilled more bone down and removed the left over screw shanks.Removal was completed, but with difficulty and instrument and implant failures.30 minutes surgical delay.Purpose of revision surgery to remove hardware - patient requested.
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Manufacturer Narrative
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Method: device inspection and device history review
results: the screw was confirmed visually to have a separated tulip head.Conclusion: the patient had achieved fusion and wanted the implants removed.It was not known if the screws were inserted tightly against the vertebral body and/or bony growth caused the head to be difficult to remove so the cause is multifactorial.
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Event Description
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It was reported that; removal at c3-t1.Removed blockers and rods with ease.Screw drivers stripped out while attempting to remove screws.Went through several drivers- each stripping out.Surgeon attached a small piece of rod and torqued down blocker to attempt to back out screw using the rod.The tulip popped off on 3 out of the 6 screws he used this method.Surgeon drilled more bone down and removed the left over screw shanks.Removal was completed, but with difficulty and instrument and implant failures.30 minutes surgical delay.Purpose of revision surgery to remove hardware - patient requested.
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Search Alerts/Recalls
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