Catalog Number OCN005 |
Device Problem
Break (1069)
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Patient Problem
Intraoperative Pain (2662)
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Event Date 06/07/2019 |
Event Type
Injury
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Manufacturer Narrative
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Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Pre-operative diagnosis for this procedure: compression fracture with tumor type of procedure: implant of pedicular screw for arthrodesis levels implanted: t5 and t6 it was reported that intra-op, when trying to remove the needle after the cement was delivered the hubs of the needle broke off making it extremely difficult to get the trocar out of the patient.There was a delay in overall procedure time.Patient had a lot of pain due to the force and wiggling of the needle it took to get it.No treatment or additional surgery performed as a result of this event.Pain was addressed by giving more pain medicines.No other post-op complications were reported.
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Manufacturer Narrative
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Product analysis results: visual and optical inspection confirmed the cannula was returned with the hub pulled from the shaft.On the cannula, the knurling was present as well as the flair on the backside of the shaft.There was cement noted inside the inner diameter of the hub.It appears the shaft was separated from the plastic hub from excessive force.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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