WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: MATRIXMANDIBLE; PLATE, FIXATION, BONE
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Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional patient identifier : (b)(6).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.This report is for an unk - plates: matrixmandible /unknown lot.Part and lot numbers are unknown; udi number is unknown.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.
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Event Description
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It was reported that, on an unknown date surgeon was not satisfied with the milled plate that was received.The case was reprocessed for a new plate design and for guiding predrilling on the new plate.The surgeon prior to revising the plate design called in to discuss the case, stating that the plate did not fit well on the anterior portion of the mandible and bent more superior than it was desired.This report is for one (1) unk - plates: matrixmandible.This is report 1 of 1 for complaint (b)(4).
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Search Alerts/Recalls
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