Catalog Number UNK_SPN |
Device Problems
Break (1069); Detachment Of Device Component (1104); Material Integrity Problem (2978); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2017 |
Event Type
Injury
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Event Description
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It was reported that; the customer reported that the occipital plate broke after implantation and that one of the connectors connecting the plate and the rod has broken off.The surgeon reported that the patient had heard a clicking noise.The surgeon plans to revise the patient.
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Manufacturer Narrative
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Method:risk assessment; results: device history, visual inspection and manufacturing review were not reviewed because no parts or lot numbers were provided.Conclusion: the root cause could not be determined due to lack of patient information.
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Event Description
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It was reported that; the customer reported that the occipital plate broke after implantation and that one of the connectors connecting the plate and the rod has broken off.The surgeon reported that the patient had heard a clicking noise.The surgeon plans to revise the patient.
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Search Alerts/Recalls
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