Production process analysis: a review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.User (surgeon and patient) information analysis: on (b)(6) 2023 patient (b)(6) patient underwent a revision procedure, during which a broken screw was replaced, along with a shorter mid-c & a new extender.On (b)(6) 2023, patient (b)(6) was seen for a post-op visit. during revision surgery on (b)(6) 2023, they cultured a film between the inner and outer sleeve of the mid-c. after over 1 week, the anaerobic side grew p.Acnes (aka cutibacterium acnes).The patient was started on doxycycline 100 mg twice a day and scheduled for a follow up visit on (b)(6) 2023.No other issues or concerns were noted at the time.Risk assessment: the risk of late infection is a known risk that was assessed and recorded by the product risk management file.The current late infection rate is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk of infection is addressed in the ifu as potential risks associated with the mid-c system and spinal surgery generally the risk has been quantified, characterized, and documented as acceptable within a full risk assessment.
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On (b)(6) 2023 patient (b)(6) patient underwent a revision procedure, during which a broken screw was replaced, along with a shorter mid-c & a new extender.On (b)(6) 2023, patient (b)(6) was seen for a post-op visit.During revision surgery ((b)(6) 2023) they cultured a film between the inner and outer sleeve of the apifix.After over one week, the anaerobic side grew p.Acnes.The patient was started on doxycycline 100 mg twice a day.
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