Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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The user facility is foreign; therefore a facility medwatch report will not be available.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report one of four for the same event; see also 0002184052-2016-00076, 00077 and 00078.
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Event Description
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The sales associate reported that a percutaneous screw placement l4-l5 with listhesis gr.1 - rod insertion 50mm - direction cranial to caudal.Caudal set screw insertion was performed.It is reported the physician was very gentle with the set screw driver, no force was used however the set screw thread broke spontaneously.The physician removed the set screw first, then removed the rod and removed the screw.Another screw was placed using another extender sleeve and the same rod was used to complete the surgery without any further issues.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Report one of four for the same event, reference 0002184052-2016-00076-1, 00077-1 and 00078-1.
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Manufacturer Narrative
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The returned screw was found to be disassembled; the complaint is confirmed.There are no indications of manufacturing issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding implant handling.
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Search Alerts/Recalls
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