Catalog Number 04.601.001 |
Device Problem
Break (1069)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on an unknown date, a surgery was performed using the vertical expandable prosthetic titanium rib ii (veptr ii) system.On (b)(6) 2017, the patient underwent the hardware removal surgery where the implanted s-rod ø6 (unknown left or right) was removed or replaced due to breakage.The hook was broken at its shaft part.The screw heads part of the parallel connector 5.0/6.0 was broken, therefore the driver did not work and the surgeon needed to cut the connector for extraction.It was considered the screw heads were broken during the insertion operation of the implant.The revision surgery was successfully completed.Patient outcome reported as okay.This report is for one (1) 90 deg ti s-hook/left this is report 2 of 3 for complaint (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Further it was clarified that the breakage of the rod and hook was confirmed through an x-ray after initial surgery on an unknown postoperative date.Also, it is unknown whether the screw heads (part of the parallel connector) were broken during initial surgery or not.
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Search Alerts/Recalls
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