Catalog Number XXX-DURASEAL |
Device Problems
Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Event Description
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Post operative csf leak was reported.It was unknown if the event lead to an increase of surgery time.The issue was detected because of a market study on duraseal.Linked to mfg.Report number: 3003418325-2017-00019.
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Manufacturer Narrative
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Additional information received on 8nov2017.It was reported that the surgeon had a couple of patients that he operated for a spinal cord lipoma where he used duraseal and leaked.To the best of his recollection, the leak was present under the skin since day one or two post op.Then it came through the skin and the patients needed to go back to the theatre for a wound repair.In one occasion, he had to leave the wound open and redress it in the theatre every other day for a couple of weeks.His patients are all pediatric.It happened in 2015/2016.It was reported that these lipoma cases were particularly challenging and it is very difficult to obtain a watertight closure.Often the edges were imperfect and the dural patch leaves a few holes patent.The surgeon has now stopped using any sealant since he doesn¿t believe they can be of any help.He spends more time suturing the patch, reduce the size of the opening and reinforce the construct with additional superficial layers.No further additional information was provided.
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Manufacturer Narrative
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Integra has performed a thorough review of the reported incident.There was no product received back (device used), and no lot number identified, as such a dhr review could not be performed.At the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.With the information provided a root cause could not be determined, as there is no way to reliably determine why the reported condition occurred.
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Search Alerts/Recalls
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