Catalog Number UNK_SPN |
Device Problems
Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
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Patient Problems
Injury (2348); No Known Impact Or Consequence To Patient (2692)
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Event Date 06/20/2017 |
Event Type
Injury
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Event Description
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It was reported that; i received a call today from sales rep, indicating that a patient is looking for compensation for a revision surgery he had involving a set screw back out.It was communicated that this patient had a previous revision surgery due to a screw back out and is now scheduled for an additional revision surgery due to a screw back out on (b)(6) 2017.
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Manufacturer Narrative
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Date of implant: (b)(6) 2017.Method: risk assessment; result: device history review could not be performed as the reported device was not properly identified.Device evaluation could not be performed as no items were returned.Complaint history review could not be performed as the reported device was not properly identified.Conclusion: the root cause of the reported event could not be determined because no device and/or insufficient information was provided for review.
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Event Description
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It was reported that; i received a call today from sales rep, indicating that a patient is looking for compensation for a revision surgery he had involving a set screw back out.It was communicated that this patient had a previous revision surgery due to a screw back out and is now scheduled for an additional revision surgery due to a screw back out on (b)(6) 2017.
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Search Alerts/Recalls
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