Associated medwatch-reports: 9610612-2020-00059, 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 required.
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