Synthes is submitting this report as a result of remediation activities related to synthes ous service and repair files legacy review/remediation protocol-complaint handling and mdr reporting.Blank fields on this form indicate the information is unknown, unavailable or unchanged.Device listed in this report is used for treatment, not diagnosis.Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.Device returned for repair.An assignable root cause is undetermined.Customer replaced device in lieu of repair.Device was returned without repair on (b)(4) 2012.Placeholder.
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