Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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The device was not returned.However, photographs were provided which were used for the evaluation.The tulip was found disassembled from the shaft and there was deformation on the swivel ring.Based on the deformation seen on the lips of the swivel ring, it is likely that while tightening the polyaxial screw, a very high force was applied to the screw head causing the material on the ring to push back, which locked it in place.Following this event, if any subsequently loosening occurred for adjustment of the screw, this would have made the implant no longer locked in place so the deformation would allow for the screw to disassemble.A review of the manufacturing records did not identify any issues which would have contributed to this event.
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