It was reported to aesculap inc.On an ess surgeon activel survery (reporting during the time frame 1feb2020 to 31jan2021), unspecified activel spine implant was used during a total disc replacement (tdr) procedure performed on an unknown date.According to the complaint description, the surgeon reported an adverse event without details about the issue.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: 9610612-2021-00544 ((b)(4) - ae-qas-sp42).9610612-2021-00557 ((b)(4) - ae-qas-sp42).9610612-2021-00558 ((b)(4) - aesculap010).
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Corrected information - b1.Associated medwatch reports: 9610612-2021-00544.9610612-2021-00557.9610612-2021-00558.Investigation: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review - due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Conclusion and measures / preventive measures: because there are no products and only minor information available, a definitive root cause analysis is not possible.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.Based upon the investigations results a capa is not necessary.
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