Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Foreign: (b)(6).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-02894, 0001825034-2020-02911.
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Event Description
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It was reported that during implantation of the g7 system, the surgeon could not lock the liner into place.A smaller size was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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Upon reassessment of the reported event, the event was determined to be not reportable as there was no device problem found but rather off-label use of the device.The surgeon used ti screws that are not compatible with g7 cups, the ti screws would not sit flush in the cup leading to the liner not seating as well.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon reassessment of the reported event, the event was determined to be not reportable as there was no device problem found but rather off-label use of the device.The surgeon used ti screws that are not compatible with g7 cups, the ti screws would not sit flush in the cup leading to the liner not seating as well.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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