It was reported that after using a regeneten implant as treatment for a full-thickness rotator cuff repair shoulder arthroscopy surgery, patient required a revision surgery as a result of a regeneten unknown implant failure.Post operatively and prior to the revision surgery patient presented inflammation, pain and stiffness.Patient current status is unknown.
|
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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 specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.Insufficient product identification information was provided, and thus, an instruction for use review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states that its noted the revision was done due to inflammation, pain, and stiffness, as of the date of this medical investigation, the requested clinical documentation has not been provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.The clinical root cause of the reported inflammation, pain, stiffness, and subsequent revision could not be confirmed.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Should any additional clinical information be provided, this complaint will be re-evaluated.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.Corrected data: h6: health effect - clinical and impact code.
|