Catalog Number 07.02010.001 |
Device Problem
Biocompatibility (2886)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Rash (2033); Swelling (2091)
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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 numbers 3012447612-2020-00629 thru 3012447612-2020-00642.
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Event Description
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It was reported that the patient is having a possible allergic reaction to some spinal implants.The installed implants include an epic construct and a breckenridge cage.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report 13 of 14 for this event.
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Manufacturer Narrative
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Corrected information in b5.Information added to d8 and h6: component, investigation type, findings, and conclusions.This follow-up report is being submitted to relay additional information.Summary: the complaint is unrefuted for the vitality construct causing an allergic reaction.Medical records were not provided for review.Device evaluation: product was not returned as it remains implanted.A device evaluation could not be performed.Potential cause: root cause was unable to be determined with the available information.Dhr review and related actions the lot numbers were not provided, so the dhr review could not be performed.Device use: these devices are used for treatment.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 the patient is having a possible allergic reaction to some spinal implants.The installed implants include a pedicle screw construct.The patient is allergic to nickel and may be sensitive to cobalt chrome.Allergy tests are on-going and a plan for care has not yet been made.This is report 13 of 14 for this event.
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Search Alerts/Recalls
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