Patient (b)(6) underwent an initial subchondroplasty procedure on (b)(6) 2018 for a stress fracture without complications; there were no concomitant procedures performed.The patient experienced increased pain 6 months post-operatively and received treatment in (b)(6) 2019; the specific event date is unknown.The operative notes and surgical documentation were received for the event.Additionally, the lot number for the device in question is known; the dhr will be reviewed as a part of the investigation.As additional information about the event is reported, a supplemental report will be submitted with any additional findings.
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The patient underwent the initial scp procedure on (b)(6) 2018 with treatment of left medial first cuneiform with noted pre-operative stress fracture.There were no complications during the scp procedure, and no additional procedures were performed.The surgery proceeded as planned and post op pain scores are as anticipated.Patient presented at 6 month office visit with pain and inflammation and treated conservatively, the specific date of the event is unknown.Pain score at 12 month visit returned back to 2/10.The patient will continue to be monitored.If further information becomes available, the complaint investigation will be reopened.The dhr for the finished goods lot was reviewed, and no anomalies related to the complaint condition were noted.The product was not returned for evaluation, as it remains implanted.
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