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Model Number PLT-1008 |
Device Problem
Device Appears to Trigger Rejection (1524)
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Event Date 03/23/2023 |
Event Type
Injury
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Event Description
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Inion plt-1008 was used in the lower eye orbital, and eyelid ectropion occured about two months later.Reoperation was needed.
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Manufacturer Narrative
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Eyelid ectropion occurred about two months later after the plt-1008 was used in the orbital floor.It is unclear whether inion plate has contributed to the event, as eyelid ectropion is expected to be more dependent on the operation technique than the implants used.According to the information received, two surgeons provided their opinion stating that regardless whether an absorbable bone plate or the ao system is used at the orbital floor, there is a risk of eyelid ectropion, and this seems to be related to the method and technique of suturing, with no relation to the implants used.The ectropion is also not caused due to polymer degradation products, as the polymer degradation has hardly started at 2 months.Nevertheless, as a secondary surgery was conducted and the role of inion plates has not been explicitly closed out by the reporting surgeon, this event is reported.
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Manufacturer Narrative
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The implant plt-1008 and screws were removed in the re-operation.At the time of receiving additional information, the ectropion had not yet resolved.On march 28, (b)(6) dr.Performed implant removal surgery.This operation took out plt-1008, but did not remove plt-1083, but there were still ectropion after the operation.In the case of eversion, the target did not do anything.(without implant anything just removed plt-1008 and screws).
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Search Alerts/Recalls
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