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Catalog Number 400.834S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Confusion/ Disorientation (2553); Unspecified Tissue Injury (4559)
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Event Date 11/01/2023 |
Event Type
Injury
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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.B3: event occurred on an unknown date in (b)(6) of 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is (b)(6) 2018.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from china reports an event as follows: it was reported that the patient in question had a cranioplasty procedure on (b)(6) 2018.During a recent examination in (b)(6) of 2023, it was discovered that the titanium mesh used during the surgery had been fractured.This resulted in damage to the scalp and exposure of the implant.As a result, a revision procedure was deemed necessary but has not been scheduled yet.No further information is available.This report is for a ti low profile neuro screw self-drilling 4mm.This is report 10 of 10 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.H3, h4, h6: the device associated with the reported event was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Based on the investigation findings and the inability to confirm the reported event or draw any conclusions about the root cause, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part:400.834s, lot:l664904, manufacturing site: werk bettlach, supplier: na, release to warehouse date: 22 nov 2017, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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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Event Description
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The patient was experiencing confusion and was admitted to the hospital.This report is related to (b)(4), which capture additional impacted products.
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Search Alerts/Recalls
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