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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Decreased Sensitivity (2683); Skin Inflammation/ Irritation (4545)
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Event Type
Injury
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Event Description
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Device report from synthes reports an event in belgium as follows: it was reported that a dua summary report was received which includes adverse events/complications on lcp ulna osteotomy system 2.7.Patient id (b)(6) patient experienced pain and plate irritation, revision surgery, aenrpp; patient id (b)(6) fracture and pseudoarthrosis, revision surgery, aenrpp; patient (b)(6) decreased range of motion, revision surgery, aenrpp.; patient (b)(6) plate irritation and delayed union, revision surgery, aenrpp; patient (b)(6) mild pain, mild sensory disturbance, plate irritation, revision surgery, aenrpp.This report is for an unknown lcp ulna plate (patient id (b)(6)) product complaint (b)(4) is related to (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b3: unknown event date; study completed june 15, 2017-february 22, 2022.D1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown ulna plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.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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Search Alerts/Recalls
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