Macfarlane, r.J., miller, d., wilson, l., meyer, c., kerin, c., ford, d.J., & cheung, g.(2015, january 27).Functional outcome and complications at 2.5 years following volar locking plate fixation of distal radius fractures.Retrieved october 17, 2017, from (b)(4).The product was not available for return.Without the opportunity to examine the complaint device, root cause cannot be determined.Part and lot identification are necessary for review of device history records and complaint history, neither were provided.Risks associated with reported condition are addressed through the warnings in the package insert as a part of design control risk management.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted late as it has been identified in remediation.
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