Model Number MID-C 95 |
Device Problems
Unintended Movement (3026); Noise, Audible (3273)
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Patient Problems
Failure of Implant (1924); Discomfort (2330)
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Event Date 10/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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First investigation: 1.1.Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.1.2.User (surgeon and patient) information analysis: the revision surgery was done on (b)(6) 2021, the doctor informed apifix that at re-op he turned the rachet from neutral to rachet and it seems to work well, so he believes that the problem is solved.The patient stopped feeling what she felt and is doing fine.The company does not have any other information as to why and if the ratchet was on neutral and as the implant was not retrieved failure analysis can't be done.Risk assessment: at the time of this report ((b)(6) 2021), the company's incident rate of clicking noise is (b)(4) the company continues to monitor this type of event routinely.
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Event Description
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The patient had a correction surgery on (b)(6) 2021 due to clicking and uneasiness.
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Manufacturer Narrative
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First investigation: 1.1.Production process analysis: a review of the dhr demonstrated that the mid-c system was manufactured, tested, and released according to specification.1.2.User (surgeon and patient) information analysis: the revision surgery was done on (b)(6) 2021, the doctor informed apifix that at re-op he turned the rachet from neutral to rachet and it seems to work well, so he believes that the problem is solved.The patient stopped feeling what she felt and is doing fine.The company does not have any other information as to why and if the ratchet was on neutral and as the implant was not retrieved failure analysis can't be done.Risk assessment: at the time of this report ((b)(6) 2021), the company's incident rate of clicking noise is (b)(4) the company continues to monitor this type of event routinely.
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Event Description
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The patient had a correction surgery on (b)(6) 2021 due to clicking and uneasiness.
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Search Alerts/Recalls
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