Catalog Number PRLSN2404 |
Device Problem
Fracture (1260)
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Patient Problems
Fall (1848); Fracture, Arm (2351)
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Event Date 01/18/2015 |
Event Type
Injury
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Manufacturer Narrative
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Examination of the production records of the involved device did not reveal a deviation that may have contributed to the reported case.Examination of the involved device, including under microscope, did not reveal signs of fatigue, and led to the conclusion that the plate broke due to a strong impact.This conclusion is in accordance with the report received by the manufacturer, that the patient fell on his arm, a relatively short period after the operation, i.E., before the fractured bone healed and united.This report is submitted following an fda inspection at the manufacturer facility.
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Event Description
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On (b)(6) 2015, a piccolo composite dvr plate and a piccolo composite one third tubular plate were implanted in the radius and ulna, respectively, of a (b)(6) patient.After approximately 5 weeks, the patient fell from standing position on out-stretched arm, resulting in breakage of the dvr plate.A second surgery was performed, replacing the dvr plate with another piccolo composite dvr plate, while leaving the 1/3 tubular plate in situ.
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Search Alerts/Recalls
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