STRYKER TRAUMA KIEL END CAP, STANDARD T2 TIBIA Ø8 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 1822-0003S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Irritation (1941); Reaction (2414)
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Event Date 12/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available for return, device is still implanted.
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Event Description
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It was reported, allergic reaction, skin redness 10 weeks post surgery.
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Event Description
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It was reported, allergic reaction, skin redness 10 weeks post surgery.
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Manufacturer Narrative
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Received product data revealed the item was manufactured with titanium ti6al4v eli (astm f 136) which is intended for implantation.No indications of material, manufacturing or design related problems were found during the investigation.The reported issue is known within the product's risk management file.Based on the insufficient information provided, the root cause could not be determined.If any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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