|
The reported product problem/issue was a bent base.The complaint could not be confirmed as there were no samples, pictures or videos received; the review of the last three trend reports was completed and no trends were identified for the specified material number and its corresponding defect type.Without a sample received, it is difficult to determine a true root cause for the reported issue.The division performs quarterly trending on all complaints received and will initiate further investigation and/or supplier corrective action requests based on trending results.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.
|