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Catalog Number LXMC16 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/01/2024 |
Event Type
Injury
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Event Description
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It was reported that it was seen in an x-ray that the linx device was discontinuous.Device is still implanted.
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Manufacturer Narrative
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(b)(4).Date sent: 4/26/2024 b3: only event year known: 2024 d6a: exact date is unk.Assumed first month of the year and first day of the month.Lot number was received and dhr is pending review.When the review is completed, a supplemental medwatch will be sent with a summary of the evaluation.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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(b)(4).Date sent: 5/21/2024.Investigation summary: an analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device 16424 number, and no non-conformances related to the malfunction were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.
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Search Alerts/Recalls
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