Catalog Number MB3XXX |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3004788213-2020-00213.
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Event Description
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It was reported that two mobi-c implants were not supporting correctly post-operatively, and a second surgery was performed.No further information has been provided.This is report two of two for this event.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Summary: the complaint is unrefuted for two (2) of two (2) mobi-c implants (pn mb3xxx) for the failure of not causing enough support post-op, leading to revision surgery.This device is used for treatment.No medical records were provided with the complaint.Inspection: the product was not returned and no photos were provided, so an evaluation is unable to be performed.Dhr review: the lot numbers were not provided, so the dhrs are unable to be reviewed.Potential root cause: the product was not returned and no photos were provided, so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Event Description
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It was reported that two mobi-c implants were not supporting correctly post-operatively, and a second surgery was performed.No further information has been provided.This is report two of two for this event.
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Search Alerts/Recalls
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