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Model Number C01A-J |
Device Problem
Coagulation in Device or Device Ingredient (1096)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This product is not marketed in us but a similar device with product number c01a with 510(k)# k041584 and udi (b)(4) is marketed in us.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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Information was received from a healthcare professional via a field contact regarding a patient with a pre-operative diagnosis of primary osteoporosis, undergoing a spinal therapy for a compression fracture.It was reported that early hardening of cement occurred, cement was made again using substitutes; another kit was opened and the procedure was performed successfully by using a new product.There was a delay of less than 60 mins.The product did not come in contact with the patient.There were no patient symptoms/complications.The cement was mixed for about 30 seconds.Initial reporter information and patient information cannot be provided due to the restriction by the privacy regulation.The product was discarded.Levels implanted: th12 device status reason : never implanted procedure/therapy: bkp.
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Search Alerts/Recalls
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