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Catalog Number 411.906S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Loss of consciousness (2418)
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Event Date 10/13/2011 |
Event Type
Injury
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Event Description
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Device report from synthes reports an event in russia as follows: event description: a customer has requested the information metal content of the following implants: 447.100, 411.906, 411.910.Item lot number data is not available / not saved.(!) the request was received in connection with the discovery of an excess of aluminum in the patient's body.A decision is made to remove the implants.The surgery was done in 2011.Date of detection of high aluminum content: april 2021.The patient found an increase in aluminum levels through a laboratory blood test as part of a health check.The patient purchased the implants at the own expense.Symptoms that the patient is currently experiencing: blurred consciousness, fatigue.The client is worried, because the excess of 6 times aluminum is a high risk of developing dementia and alzheimer's disease.Were the implants already explanted? no, the need for explantation was associated with a suspected effect of the medical devices on the increase in the content of aluminum in the patient's blood, but it was found that these medical devices do not contain aluminum in the composition.This report is for one (1) mandib-cortscr ø2 self-tap l6 ti.This is report 1 of 7 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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