Catalog Number 150401207 |
Device Problem
Difficult to Open or Remove Packaging Material (2922)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2024, when the implant in question was opened, the lid stuck and did not peel off, and the implant in question was taken out by cutting it with a scalpel.The surgery was completed successfully without any surgical delay.No further information is available.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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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Search Alerts/Recalls
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