Model Number N/A |
Device Problem
Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Medical devices: item # unk, hip-unknown-screws-unk, lot # unk.The event occurred in (b)(6).Multiple reports have been submitted for this event.Please see associated report: 0001825034-2018-10773.
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Event Description
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It was reported that the bone screw planned for a custom device was too long.The screw came in contact with an in situ trauma device.An alternate, shorter bone screw was used to complete the surgery.The surgeon was satisfied with the result.No further complications were reported.Attempts have been made, and no further information has been provided.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Upon further review of event, the investigation results conclude that no problem can be identified with this device.
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Manufacturer Narrative
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This report is being submitted to relay additional information.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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