Model Number AE-QAS-SP42 |
Device Problems
Patient-Device Incompatibility (2682); Insufficient Information (3190)
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Patient Problems
Failure of Implant (1924); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
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Event Description
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It was reported that there was an issue with aesculap010 - aesculap surgical instruments.According to the complaint description, the surgeon reported an adverse event without details about the issue.The type of indication was total disc replacement.Additional information was not provided.Additional patient information is not available.The adverse event is filed under (b)(4) reference (b)(4).Associated medwatch-reports: 9610612-2021-00543 ((b)(4) - aesculap010).9610612-2021-00559 ((b)(4) - aesculap010).9610612-2021-00560 ((b)(4) - aesculap010).
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Manufacturer Narrative
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Associated medwatch reports: 9610612-2021-00543.9610612-2021-00559.9610612-2021-00560.Investigation: up to now, products not provided.Therefore, no investigation possible.Batch history review: due to the fact that neither an article nor a lot number was provided, a review of the device history records must remain incomplete.Explanation and rationale/conclusion and root cause: because there are no products and only minor information available, a definitive root cause analysis is not possible.Because the device history record is without any deviation, a material defect or manufacturing failure can be excluded.Following causes are possible: - wrong system configuration selected by the user.- wrong implant size chosen by the user.- end plate formed too strong by the user.- design layout unsuitable.- inadequate patient behaviour.Corrective action: a capa is not necessary.
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Event Description
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Update: the information was received via a surgeon survey for activl products, for the reporting period (b)(6) 2020-(b)(6) 2021.The leading material was not specified: ae-qas-sp42 - collect.No.Qas spine anterior stabilis was selected.
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Search Alerts/Recalls
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