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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Impaired Healing (2378)
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Event Type
Injury
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Manufacturer Narrative
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Patient initials: (b)(6).Patient weight is unknown date of event: unknown.This report is for four unknown pangea polyaxial screws/unknown lots.Part and lot numbers are unknown; udi number is unknown.Additional product codes: mni, mnh, kwp, kwq.Implant date: unknown date in 2006.Device was reportedly not explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent an unknown fusion procedure at the l4-l5 level on an unknown date in 2006.The patient was implanted with synthes pangea screws, rods, and locking caps.On an unknown date, it was determined that there was a non-fusion and instability at the implant level.On (b)(6) 2016, the patient was returned to the operating room where they were implanted with a synthes opal spacer.After implanting the spacer, the surgeon re-attached the rods to the screws, and re-tightened the locking caps; the original devices were not explanted.The surgery was completed successfully.This report is for four unknown pangea polyaxial screws.This is report 1 of 3 for (b)(4).
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Search Alerts/Recalls
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