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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Date of event: alonso-rodriguez, e., et al (2015) polyetheretherketone custom-made implants for craniofacial defects: report of 14 cases and review of the literature.Journal of cranio-maxillo-facial surgery 43(2015)1232-1238.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.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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Literature article received: this report is being filed after the subsequent review of the following literature article: alonso-rodriguez, e., et al (2015) polyetheretherketone custom-made implants for craniofacial defects: report of 14 cases and review of the literature.Journal of cranio-maxillo-facial surgery 43(2015)1232-1238.A retrospective review was conducted of 14 patients who underwent peek craniofacial reconstruction between 2008 and 2014.Over the 6 years, 14 patients (4 men and 10 women; mean age 42.7 years) underwent craniofacial reconstruction using a peek psi (polyetheretherketone- patient specific implant) due to defects arising from different pathologic conditions including trauma (1 patient), congenital deformities (4 craniofacial dysplasias and 1 facial cleft), and various benign and malignant tumors (8 cases).The report is for unknown peek implant and refers to the following complications: patient 8, female, age (b)(6), implant infection.This is report 3 of 5 for (b)(4).
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Search Alerts/Recalls
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