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Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 06/26/2017 |
Event Type
Injury
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Manufacturer Narrative
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510k: this report is for an unknown screws: cmf/unknown lot.Part and lot numbers are unknown; udi number is unknown.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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017 after preparing the patient for a partial hemimandibulectomy procedure, it was found that the provided surgical boxes did not contain the complete materials.The surgical team requested new materials from the facility, but they were not available.It was decided by the family and clinical team to abort the procedure instead of keeping the patient under general anesthesia while awaiting a new set of surgical boxes from the supplier.This report is for one (1) unk - screws: cmf.This is report 4 of 4 for (b)(4).
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Search Alerts/Recalls
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