Catalog Number UNK_WTB |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/17/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient had a superficial infection.The patient was treated with irrigation and debridement with saline and vancomycin powder.All the hardware was left in the patient as the doctor deemed the infection was not deep enough to have been a result of the implants.
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Manufacturer Narrative
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The device is not available for evaluation as it remains implanted in the patient. a review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on a supplemental report.
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Manufacturer Narrative
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Please disregard the report linked to mfr # 0001649390-2023-00047, additional information was received indicating that the alleged deep infection involves (7) stryker devices not (8) which were successfully reported under the following numbers: mfr # 0001649390-2023-00152, mfr # 0001649390-2023-00153, mfr # 0001649390-2023-00154, mfr # 0001649390-2023-00155, mfr # 3000931034-2023-00205, mfr # 0001649390-2023-00156 and mfr # 0001649390-2023-00157.And therefore mfr# 0001649390-2023-00047 will be officially cancelled out in our system.
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Event Description
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It was reported that the patient presented with superficial infection.The physician treated the infection with irrigation and debridement with saline and vancomycin powder.All the hardware was left in the patient as the doctor deemed the infection was not deep enough to have been a result of the implants.The patient was administered and prescribed antibiotics.
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Search Alerts/Recalls
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