WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0 CANCELLOUS BONE SCREW FULLY THRD/18; PLATE, FIXATION, BONE
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Model Number 206.018 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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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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Complainant part is not expected to be returned for manufacturer review/investigation.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, an order had a ripped on the side from the actual rip opening when it arrived from colorado and it was empty.No patient involvement.This report is for one (1) 4.0 cancellous bone screw fully thrd/18.This is report 2 of 2 for complaint (b)(4).
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Search Alerts/Recalls
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