Model Number 1001.001 |
Device Problem
Device Slipped (1584)
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Patient Problem
Laceration(s) (1946)
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Event Date 02/01/2024 |
Event Type
Injury
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Event Description
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Distributor informed us on (b)(6) that one of our products was involved in a procedure (posterior cranial fusion) resulting in a slippage, in which the treated patient sustained a laceration.
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Manufacturer Narrative
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The product which, according to customer feedback, was involved in the incident described has not yet arrived at the manufacturer's site for investigation.The results of the product investigation and any further findings in connection with the described incident will be presented in a follow-up report after receipt of the product.
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Manufacturer Narrative
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The device in question was not sent in to the manufacturer's site for investigation.If the product is subsequently sent in for inspection, any findings will be presented in a further follow-up report.
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Search Alerts/Recalls
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