Model Number 101-9812 |
Device Problem
Material Integrity Problem (2978)
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Patient Problems
Injury (2348); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/20/2020 |
Event Type
malfunction
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Event Description
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It was reported that during the implant procedure the top of the spacer implant came off.The physician attempted to retrieve the spacer and was unable to successfully.To avoid possible additional complication, he decided to leave the spacer in place.The patient was doing well post operatively.
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Event Description
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It was reported that during the implant procedure the top of the spacer implant came off.The physician attempted to retrieve the spacer and was unable to successfully.To avoid possible additional complication, he decided to leave the spacer in place.The patient was doing well post operatively.
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Manufacturer Narrative
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Device technical analysis: visual inspection of the returned spindle and an actuator from a 101-series 12 mm implant of lot number 800330 revealed components of the implant clearly suggested that the spindle cap was completely sheared off from the implant body.Since only retrieved components were returned, no functional testing could be performed.The damage to the implant indicates failure likely due to a combination of deployment against resistance, e.G.Bone, and physician failing to correctly attach the inserter to the spacer.Investigation conclusion: the investigation concluded that the reported event of the top of the spacer implant coming off during implant procedure was confirmed through device analysis therefore the most probable root cause is traced to unintended use error caused or contributed to event.
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Event Description
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It was reported that during the implant procedure the top of the spacer implant came off.The physician attempted to retrieve the spacer and was unable to successfully.To avoid possible additional complication, he decided to leave the spacer in place.The patient was doing well post operatively.
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Search Alerts/Recalls
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