WRIGHTS LANE SYNTHES USA PRODUCTS LLC PSI SD800.539 PEEK IMPLANT; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
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Model Number SD800.539 |
Device Problem
Defective Device (2588)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 synthes reports an event in the usa as follows: it was reported that on an unknown date, there were issues with the fit of this psi.The surgery was not able to be completed.Procedure and patient outcome were unknown.This complaint involves (1) device psi sd800.539 peek implant.This is report 1 of 1 for complaint (b)(4).
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Search Alerts/Recalls
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