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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Information was received from a healthcare provider (hcp) via manufacturer representative regarding a patient who has underwent spinal therapy for screw removal.It was reported that when the screw head was moved using the screw head positioner, it had broken from screw head bottom.The broken bone screw shaft was left inside the patient bone and no further complications or symptoms were reported.Additional information was received via manufacturer representative that the lot number of the reported product is unknown as the product is been discarded.Since there is a screw shaft in the deep part of the bone, there is no plan to remove it by re-operation in the future.The reported product was implanted in the first surgery ((b)(6) 2013) and this is re-operation for implant removal.Implant date is (b)(6) 2013 and explant date is (b)(6) 2022.There was delay in treatment, intervention and hospitalization.
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