Catalog Number 7701-1040 |
Device Problem
Biocompatibility (2886)
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Patient Problem
Reaction (2414)
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Event Date 10/26/2018 |
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 reports 3012447612-2018-00942 thru 3012447612-2018-00952.
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Event Description
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It was reported that a patient developed an allergic reaction about 6-8 months post-operatively.The surgeon believes it may possibly be related to the implants.A course of action for treatment has not yet been decided upon.This is report two of eleven for this event.
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Manufacturer Narrative
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Additional information: results and conclusions - the device was not returned for evaluation so no results are available and no conclusions can be drawn.The manufacturing records were unable to be reviewed since the lot number is unknown.Allergic reaction to the implant material is a known possible complication associated with the device per its labeling.
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Event Description
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It was reported that a patient developed an allergic reaction about 6-8 months post-operatively.The surgeon believes it may possibly be related to the implants.A course of action for treatment has not yet been decided upon.This is report two of eleven for this event.
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Search Alerts/Recalls
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