Catalog Number UNK ALIGNMENT DEVICE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Pulmonary Embolism (1498)
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Event Date 03/10/2023 |
Event Type
Injury
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Event Description
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Hospital cssd wrongly identified missing pointer array for navigation.Dr was notified and decided to use standard instrumentation.The patient post operatively developed a pulmonary embolism.
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Manufacturer Narrative
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Product complaint #: (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint (b)(4).Investigation summary: no device associated with this report was received for examination.The information received, will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers, the investigation closed.Should additional information be received, the information will be reviewed.And the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) was not possible, because the required lot code was not provided.
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Search Alerts/Recalls
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