Model Number N/A |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907); Naturally Worn (2988)
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Patient Problem
No Information (3190)
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Event Date 08/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that when doctor was examining the patient, he discovered that one low profile abutment ( ilpc343u) had fractured.
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Manufacturer Narrative
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This report is being submitted to supplement.Two certain low profile one-piece abutments were returned for inspection with a piece of a low profile abutment screw.Both devices show signs of wear from use.One of the abutments is confirmed to be fractured at the threaded regions.The drive feature of the other abutment is confirmed to contain half of a fractured low profile abutment screw.The hex of the low profile abutment screw is similarly worn.The reported conditions of one fractured low profile abutment and one low profile abutment with a screw fractured into the driver feature were confirmed.The reported event could not be recreated due to the already damaged states of the devices and the nature of the alleged event.No issues were identified during investigation that show that the reported device could have caused or contributed to the reported event.A device history review and complaint history review could not be performed as the lot number of the reported devices are unknown.A definitive root cause could not be determined.Probable causes related to this event include customer error in screw torqueing or potential cross-threading, excessive occlusal forces, inadequate abutment torque, and ill fitting framework.
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Event Description
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It was reported that during a visit, the doctor was checking the patient and discovered two retaining screws and one low profile abutment were fractured.For one of the screws, the retaining part got stuck in the abutment.The abutment and stuck screw were removed.For the second screw, the doctor realized that the abutment (ilpc343u) was also fractured at the screw level.The fractured abutment was removed.There was no report of patient injury.
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Search Alerts/Recalls
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