Model Number 391-11-708 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 10/31/2019 |
Event Type
Injury
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Manufacturer Narrative
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The reason for this revision surgery was reported as unknown at this time.The previous surgery and the surgery detailed in this event occurred 7.7 years apart.The healthcare professional indicated there was no significant adverse event.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended and without incident.A review of the device history record (dhr) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and 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 needing a review.The root cause of this complaint was a revision surgery due to unknown reasons.There were no findings during this evaluation that indicate the reported devices were defective.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 event.There are multiple factors that may contribute to an event 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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Event Description
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Revision surgery due to unknown reason.
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Manufacturer Narrative
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Manufacturer narrative: the reason for this revision surgery was reported as unknown at this time.The previous surgery and the surgery detailed in this event occurred 7.7 years 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 hospital and not made available to djo surgical for examination.A review of the device history record (dhr) show that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and 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 needing a review.The root cause of this complaint was a revision surgery due to unknown reasons.There were no findings during this evaluation that indicate the reported device was defective.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 event.There are multiple factors that may contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.
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Search Alerts/Recalls
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