Catalog Number UNK_SEL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Swelling (2091)
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Event Date 11/01/2012 |
Event Type
Injury
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.This complaint has been reported during a literature review performed by the post market surveillance group.No product identification is possible.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The reviewed ifu, however, states that ¿early or late infection, both deep or superficial¿ is one of the most frequent adverse effects involving the use of internal fracture fixation devices and adverse results may be clinically related rather than device related.Also, the surgeon must warn patients of surgical risks, and make them aware of possible adverse effects.The patient should be warned that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity or trauma.Based on the available information, no relation could be established between the device and the reported event.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.Device evaluated by mfr: device disposition unknown.
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Event Description
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The manufacturer became aware of a post market clinical follow-up (pmcf) from (b)(6) medical campus ((b)(6)).The title of this report is ¿a post-market clinical follow-up (pmcf) of the treatment of fractures with the apex pins in conjunction with stryker external fixation systems¿ which was published in april 2019 and is associated with the stryker apex pin.Within that publication, post-operative complications/ adverse events were reported, which occurred between november 2012 to september 2018.It was not possible to ascertain specific device or patient information from the article; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication.Therefore, 52 complaints were initiated retrospectively for different adverse events mentioned in the journal.This product inquiry addresses pin tract infection.1 out of 15 cases.The report states, ¿subject (b)(6) was a (b)(6) caucasian female, who sustained a closed right tibia injury when her husband fell off a ladder and landed on her.A stryker hoffman 3 external fixator was applied along with 5 stryker apex pins for temporary placement.There were no additional orthopaedic related injuries; no history of tobacco use, diabetes, or osteoporosis.Subject was discharged home on post-operative day (pod) 1, non-weightbearing.Subject was 12 days out when she called the orthopaedic clinic to report concerns of ¿redness around the pin site and area of redness around her foot along with swelling.¿ the next day the subject was treated with a course of oral antibiotics due to ¿redness at the pin site around the lateral calcaneus pin¿ by the orthopaedic surgeon.Two days later the external fixator and pins were removed (15 days from initial placement); the subject was definitively treated for her fracture.The subject¿s oral antibiotics were discharged at time of surgery and no further indications in her records regarding the reported ¿redness around the pin site.¿.
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Search Alerts/Recalls
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