Associated medwatch-reports: 9610612-2020-00059.9610612-2020-00060 (400464266 sw966).9610612-2020-00061 (400464267 sw996k).Investigation results: up to now there is no product available for analysis.Batch history review: because the batch numbers are unknown up to now, a batch history review is not possible at this time.Conclusion and root cause: due to the circumstances we do not receive any devices for investigation and the lack of information it is not possible to determine a definitive conclusion and root cause for this failure.Rationale: 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.No capa necessary.
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