To date the samples have not been received by surgical specialties corporation for root cause and failure analysis.To date a lot number has not been provided and therefore we are unable to perform a lot review to determine if there were any non-conformances reports with this issue without reviewing and testing the complaint device or receiving pertinent details regarding the pre-operative preparation of the device, procedure performed, surgeon's technique, post-operative instructions or events that may have occurred and/or contributed to the reports of wound dehiscence, a definitive root cause cannot be determined at this time.When and if additional information is received a follow-up report will be filed.
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A review of the device history records for the finished good lots, did not identify any quality issues during the manufacturing, in-process, sterility records or final inspection processes.There have been no lots released for distribution which failed to meet any of the product specifications or current acceptance criteria ten (10) samples were returned, visually inspected and pull tested.All devices met usp and surgical specialties requirements.A definitive root cause for the reported events of dehiscence(s) cannot be confirmed with certainty.Wound dehiscence is one of the most common complications of surgical wounds, involving the opening of the surgical incision.There are many causes that can result in the wound opening or sutures failing during or post-operative a procedure: the patient¿s health status, poor skin quality, thin skin; the risk is higher with a patient with a weak immune system, malnutrition or chronic medical condition.The surgical procedure ¿ the risk increases with poor surgical techniques such as improper suturing, over-tightened sutures or inappropriate type of suture used for a particular procedure.Other factors - the risk is greater with smoking, obesity, premature post-surgery exercise, heavy lifting, recurrent vomiting, coughing or an improper diet that leads to constipation.Placeholder.
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