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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 06/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Event occurred in the country: (b)(6).This part is not approved for use in the united states; however a like device catalog # c01a, 510k # k041584, udi # (b)(4) was cleared in the united states.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information received from healthcare provider via manufacturer representative regarding an event happened during intra-op for a patient undergoing kyphoplasty.The pre-operative diagnosis was mentioned as primary osteoporosis.It was reported that, there was a bone cement issue.The event occurred while injecting cement into bfd.A spare bone cement was opened and used.The powdered polymer and liquid monomer were filled in the mixer.Time measurement started from the start of filling.After mixing the cement, filling into bfd was performed.Since the cement was getting harder with the 3rd or 4th bfd, the bfd that had been injected earlier were extruded with a plunger.Although filling was performed, but the cement was clearly hardened, and the physician judged that it could not be used, so spare bone cement was used and it was used without problems.There was no malfunction of bone filler device and mixer.The cement was stored at the proper temperature (below 25 degrees and kept in between 22 and 24 degrees).The cement was mixed for 35-40 seconds.There was no delay in procedure reported.The reported product(cement) did not came in contact with patient.No health damage in patient was reported.No further complications reported.
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Search Alerts/Recalls
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