Although it is unknown if the concerned device caused or contributed to the reported event, we are filing this report for notification purposes.Above mentioned device with quantity of 2 was involved in the event.The concerned product is a multi-pack which contains four devices with part# 6430530.This product is not available for market in the us.However, a like device with part# 6430530, 510k# k143375 and udi# 00643169545281 was cleared in the united states.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Pre-op diagnosis: kyphoscoliosis procedure: posterior pedicle screw(pps) fixation levels implanted: l2-5 it was reported that during surgery, after final tightening, metal pieces were confirmed and removed from the wound on the right side of l3.There was a gap between the rod and the screw somewhat, it seemed the set screw pushed the rod down onto the screw.It was unknown whether the implanted products broke or not.No metal pieces were remaining in the patient.Patient complications were reported as unknown.
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