During a procedure, on (b)(6) 2016, the doctor encounter an osteophyte near the implant site that impeded direct alignment of the sypher locking cover plate assembly to the implanted sypher spacer.The cover plate screw and the spacer insert were not properly aligned using the free-hand technique, resulting in cross-threading of the screw into the spacer insert to a degree that prevented the screw from being fully seated as well as impossible to remove the screw by unscrewing it from the cover plate.The doctor then attempted to remove the locking cover plate screw using pliers and in the process the spacer insert was pulled out of the spacer along with the locking cover plate assembly.Since the sypher spacer was firmly fixed in place with the three sypher titanium screws, the doctor decided to finish the procedure without a locking cover plate assembly.In a follow-up with the doctor on (b)(6) 2016, he indicated that the patient was doing well and that in future situations he would remove any obstructing osteophytes prior to sypher spacer implantation.Biogennix assessment: biogennix received the returned sypher locking plate assembly components related to this complaint.The investigation concluded that this complaint was a result of misalignment and cross-threading of implant components due to an osteophyte location that prevented aligned access to the implant.Visual assessment and the doctor's description of events indicate that the sypher locking plate assembly met all the specification requirements and no additional action is required as a result of this complaint.Field experience will be monitored for similar occurrence.
|