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); Pain (1994)
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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.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 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).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.12 out of 15 cases.The report states, ¿subject a1-12 was a (b)(6) year old (b)(6) female who had a fall from height.Subject injured her right calcaneus (closed fracture), right distal fibula (closed fracture) and sustained a right subtalar dislocation.A stryker external fixator with 4 apex pins was placed on the right tibia for definitive treatment.Subject was a multi-trauma with an additional orthopaedic injury, a closed right femoral neck fracture.There was a history significant for previous tobacco use.Discharged on pod 2 and placed on nonweightbearing status.Subject was seen in clinic 2 weeks after ex-fix placement for a wound check.The staff at subject¿s rehabilitation facility had called with concerns regarding red and tender pin sites.Subject presented with redness and pain around the proximal pin sites.Distally, around lateral foot pin, there was also some erythema present.Antibiotics were prescribed for a pin tract infection.Subject returned to clinic five days later and the redness had ¿regressed nicely.¿ she was continued on antibiotic therapy.At the six week post-op clinic visit the surgeon documented there were ¿no clinical signs of infection noted to the pin sites¿ and ex-fix was removed at this time, 44 days after placement.¿.
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Search Alerts/Recalls
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