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.Ifu also states: "contraindications: the physician¿s education, training and professional judgment must be relied upon to choose the most appropriate device and treatment.Conditions presenting an increased risk of failure includes: any active or suspected latent infection or marked local inflammation in or about the affected area.Adverse effects: in many instances, adverse results may be clinically related rather than device related.The following are the most frequent adverse effects involving the use of internal fracture fixation devices: conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.Increased fibrous tissue response around the fracture site due to unstable comminuted fractures.[¿] deep venous thrombosis.Avascular necrosis.[¿] subclinical nerve damage may possibly occur as a result of the surgical trauma." if any further information is provided, the investigation report will be updated.Device evaluated by mfr: device disposition unknown.
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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.14 out of 15 cases.The report states, ¿subject (b)(6) was a (b)(6) caucasian female who had a fall from height and sustained an open right ankle dislocation.A stryker external fixator with four apex pins was placed for definitive treatment.No significant health history.She was discharged on pod 1, no weightbearing.At initial post-op clinic visit, there was ¿¿no erythema or drainage from pin sites, only eschar around them as would be expected.¿ approximately 2 weeks later, the subject returned for a clinic visit and presented with a very small amount of drainage from her proximal pin site with surrounding erythema as well.Subject was prescribed antibiotics for a pin tract infection.Seven days later subject returned to the clinic and the redness had completely resolved and pin site had dried up.Ex-fix was removed 40 days after application.¿.
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