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Catalog Number 04.503.122 |
Device Problem
Break (1069)
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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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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 november 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 matrix neuro contour mesh 200mm x 200mm/0.6mm rigid.This is report 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.B3: event occurred on an unknown date in november of 2023.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is (b)(6) 2018.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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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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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 product was not returned to depuy synthes, however photos were provided for review.The x-ray review found the matrixneuro mesh-pl 200*200 t0.6 contour broken at different locations.With the information provided, it is not possible to determine the cause of this failure mode.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed.As the observed condition of the [matrixneuro mesh-pl 200*200 t0.6 contour] would contribute to the complained device issue. based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.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 # 04.503.122, synthes lot # h448818, supplier lot #na, release to warehouse date: 22 nov 2017 , manufactured by: synthes monument.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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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