Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Reaction (2414)
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Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Rushing, et al.When it is not an infection: metal allergy after the nuss procedure for repair of pectus excavatum.Journal of pediatric surgery.42:93-97.
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Event Description
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It was reported in a journal article that the patient experienced an allergic reaction following the implantation of a stainless steel pectus bar.No further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The complaint is confirmed.A journal article was referenced which evaluated metal allergy and its effects on treatment with the nuss procedure.Over an 18-year period (1987-2005), 862 patients underwent the nuss procedure.Nineteen (2.2%) were diagnosed with metal allergy.Three follow up attempts were made to attempt to gather additional information regarding the identity of the implants in these 19 cases; however, journal article author dr.Goretsky responded that he is unable to provide any additional information regarding the 19 patients with metal allergy referenced in the journal article.The dhrs for the implants involved in these events could not be reviewed due to the identities remaining unknown.There are no indications of manufacturing defects.The complaints and sales histories for the part# involved in these events could not be reviewed to calculate the occurrence rate due to the identities remaining unknown.The most likely underlying cause of the complaint is a patient condition, as these 19 cases were confirmed to be a result of a metal allergy during the study.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: b4 date of this report b5 describe event or problem d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.
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Event Description
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This follow-up report is being submitted to relay additional information.
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Search Alerts/Recalls
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