Catalog Number MC1312P |
Device Problems
Fracture (1260); Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3004788213-2021-00075.
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Event Description
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It was reported that while inserting a plate through the cage, the plate became stuck and could not be advanced or removed.The cage was broken to remove the plate.The cage was also removed and both pieces were replaced with competitive product to complete the procedure without patient impacts.This is report two of two for this event.
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Manufacturer Narrative
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Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned for evaluation.However, photos provided by the reporter confirm the device had fractured.Potential cause a definitive root cause cannot be determined with the information provided.It could be attributed to the cage being wrongly positioned.Dhr review per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use these devices are used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Event Description
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It was reported that while inserting a plate through the cage, the plate became stuck and could not be advanced or removed.The cage was broken to remove the plate.The cage was also removed and both pieces were replaced with competitive product to complete the procedure without patient impacts.This is report two of two for this event.
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Search Alerts/Recalls
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