SYNTHES GMBH 10MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 04.037.045S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Necrosis (1971)
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Event Date 05/25/2022 |
Event Type
Injury
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Manufacturer Narrative
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Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 japan reports an event as follows: it was reported that on (b)(6) 2021, the patient underwent surgery with the nail, end cap, blade, locking screw and cement in question.The surgery was completed successfully without any surgical delay.Later, on (b)(6) 2022 it was confirmed that penetration of the implant occurred due to osteonecrosis.No further information is available.This report is for a 10mm/130 deg ti cann tfna 235mm/left - sterile.This is report 4 of 5 for (b)(4).
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Search Alerts/Recalls
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