WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP LAT ANT CLAVICLE PLATE/11H/113MM; PLATE, FIXATION, BONE
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Model Number 02.112.048 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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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Event Description
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It was reported that on an unknown date, the patient underwent fixation of a shaft fracture utilizing a variable angle-locking compression plate (va-lcp) anterior plate.There were intra-operative complications reported, which patient experienced with a previous superior plate fixation which failed (not listed in this study).Hardware removal done and bone graft/grafton paste used for revision surgery.There was a union of fracture after 16 weeks duration.Patient outcome is unknown.No further information is available.This report is for one (1) 2.7mm/3.5mm va-lcp lat ant clavicle plate/11h/113mm.This is report 1 of 1 for complaint (b)(4).
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Search Alerts/Recalls
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