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Catalog Number UNKNOWN |
Device Problem
Malposition of Device (2616)
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Patient Problems
Bone Fracture(s) (1870); Loss of Range of Motion (2032); Malunion of Bone (4529)
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Event Date 11/01/2019 |
Event Type
Injury
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Event Description
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It was reported that on literature review "sagittal plane considerations during long cephalomedullary nailing: optimal distal positioning and the role of intraoperative nail bending", 1 patient with anterior cortical contact (acc) suffered from late supracondylar fracture at the distal end of the nail, after having an internal fixation surgery with the trigen intertan system.This patient became non ambulatory after the surgery and the chronicity of the late fracture was unknown.The fracture healed with a malunion.No further information is available.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).Georgiadis, g.M., stein, c.M., bair, j.M., tank, j.C., georgiadis, a.G., & redfern, r.E.(2019).Sagittal plane considerations during long cephalomedullary nailing: optimal distal positioning and the role of intraoperative nail bending.Journal of orthopaedic trauma, 33(11), 553-558.Doi: 10.1097/bot.0000000000001577.
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that patient specific supporting documentation has not been provided as of the date of this medical investigation.The images provided in the article have been interpreted within the text; therefore, further analysis of the images is not required.The clinical root cause of the reported acc/impingement, late fracture and malunion cannot not be further assessed.The patient¿s outcome beyond that which was documented in the article cannot not be determined as the patient¿s current health status remains unknown.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or potential causes that could contribute to the reported event include excessive forces applied to implant and surgical technique.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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Search Alerts/Recalls
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