Catalog Number UNK_KIE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870)
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Event Date 09/13/2019 |
Event Type
Injury
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.
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Event Description
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The manufacturer became aware of a literature published by städtisches klinikum dresden, in germany.The title of this report is ¿reduced complication rates for unstable trochanteric fractures managed with third-generation nails: gamma 3 nail versus pfna¿ which is associated with the stryker ¿gamma3 nailing¿ system.Article can be found on https://doi.Org/10.1007/s00068-019-01200-7.This report includes research done on 53 patients between the period from july 2005 to dec 2006.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses renewed trauma to the operated side with severe consequences.The report states: ¿one patient in each group suffered renewed trauma to the operated side with severe consequences.In the patient with the gamma 3 nail, the second fall threatened to cause cut out.The patient refused revision surgery.¿.
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Manufacturer Narrative
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Correction: please refer to h6 conclusion code.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible and no additional information will be requested to the customer as this serves for trending purpose.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.Based on the investigation, no definitive relation could be established between the product and the reported failure adverse consequence.However, the root cause of the event has been identified by the authors of the article.Indeed, the authors clearly indicate that the event was caused by a fall of the patient: "in the patient with the gamma 3 nail, the second fall threatened to cause cut out." based on this statement, we can conclude that the event is not device-related but associated with renewed trauma.If any further information is provided, the investigation report will be updated.
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Event Description
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The manufacturer became aware of a literature published by städtisches klinikum dresden, in germany.The title of this report is ¿reduced complication rates for unstable trochanteric fractures managed with third-generation nails: gamma 3 nail versus pfna¿ which is associated with the stryker ¿gamma3 nailing¿ system.Article can be found on https://doi.Org/10.1007/s00068-019-01200-7.This report includes research done on 53 patients between the period from july 2005 to dec 2006.It was not possible to ascertain specific device details or patient information from the report, or to match the events reported with previously reported complaints.Therefore, new complaints were initiated in the system for the post-operative complications mentioned in the report.This product inquiry addresses renewed trauma to the operated side with severe consequences.The report states: ¿one patient in each group suffered renewed trauma to the operated side with severe consequences.In the patient with the gamma 3 nail, the second fall threatened to cause cut out.The patient refused revision surgery.¿.
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Search Alerts/Recalls
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