Health Canada — Medical Devices · Canada · 2013-12-04 · Type II
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Reported risk: Complaints have been received which describe the Synfix LR Implant Holder breaking at the interface between the implant and holder. If an unretrieved device fragment remains threaded into the plate, it will not be possible to properly attach the Synfix aiming device to the implant (Plate). Proper attachment of the aiming device to the plate is required for accurate insertion of the four Synfix screws into the Synfix implant (Plate) and verebral bodies. If the tip holder should break, the potential exists for an untretrieved device fragment to be left in the Synfix-LR implant.
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