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Catalog Number 26-1221 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Information (3190)
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Event Date 04/26/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It has been reported that the device will be returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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It was reported that when the surgeon tried to make the hole with the perforator, the sealed part was caught between the bone and the perforator, and it peeled apart.Those pieces scattered into the brain; however, were successfully removed.No further information was provided by hospital.The product will be returned to your site.
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Manufacturer Narrative
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The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.
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Manufacturer Narrative
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Udi : (b)(4).The device was returned for evaluation.The perforator was visually inspected.No anomalies were observed, other than the product label be removed.Functional testing was performed.A series of holes was drilled without issue.A review of manufacturing records found no anomalies when the device was released.Based on the information provided, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Search Alerts/Recalls
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