It was reported that on literature review regeneten bio-inductive collagen scaffold for rotator cuff tears: indications, technique, clinical outcomes, and review of current literature, 2 patients developed adhesive capsulitis after a rotator cuff repair procedure using a regeneten screw.For one patient eventually improved over the 24-month study period and the other one resolved by the final follow-up.No further information is available.
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H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.Insufficient product identification information was provided, and thus, a complaint history review could not be conducted.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Insufficient product identification information was provided, and thus, an instructions for use review could not be conducted.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that per case details, ¿no further information is available.¿ smith and nephew has not received the device/adequate materials to fully evaluate the complaint.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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