This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿orthopaedic department, parc de salut mar, spain¿.The article can be found at http://dx.Doi.Org/10.1016/j.Injury.2014.12.003.The reported event of implant rupture, which required conservative treatment, could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author. more detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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The manufacturer became aware of a literature published by the ¿orthopaedic department, parc de salut mar, spain¿.The title of this report is ¿salvage for nail breakage in femoral intramedullary nailing¿, published on december 17, 2014, and can be found at http://dx.Doi.Org/10.1016/j.Injury.2014.12.003.The report is associated with the stryker ¿gamma 3 nailing system¿ and includes an analysis of the clinical data that was collected on 1246 patients.The cases in this study range from january 2003 to december 2012.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that one (1) patient experienced implant rupture in the proximal nail aperture, which required conservative treatment.The report states, ¿all these patients presented hip pain, lameness, and serious difficulty in walking during the postoperative period until the diagnosis of implant breakage was made.All of them lacked a consolidation of the fracture focus at 6 months follow-up¿.The report also states, ¿the conservative treatment was decided due to the associated morbidity as well as a lack of functional demand in these 2 patients¿.
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