Corrected data: see.Brand name, common device name,concomitant medical products.Manufacturer narrative: the reason for this revision surgery was due to pain and an infection.The previous surgery and the revision detailed in this investigation occurred 2.8 months apart.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhr) shows that item: 114812, used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports associated with the product that may have contributed to the reported event.The device was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to pain and an infection.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's pain or infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the pain or infection and inhibited the patient's immune system.There are multiple factors that may contribute to pain or infection that are outside of the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.
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