There were no reports of device malfunction, however the manufacturer found the set screw had backed out of the mating screw when reviewing the provided x-ray.The cause cannot be determined with the available information.But, this event could possibly be attributed to the fusion not healing properly, as stated by the complainant.The lot number is unknown, so the dhr is unable to be reviewed.This device is used for treatment.If any information is received which changes the information in the report, a follow-up report will be submitted.Reference reports 3012447612-2021-00169-1, 3012447612-2021-00170-1, 3012447612-2021-00222.
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It was reported that two screws broke at s1 bilaterally after being implanted for approximately 17 years.A revision surgery was performed, however, the surgeon was unable to get the proper angle to remove the screws so left them implanted.The adjacent level was added to the construct.X-ray evaluation by the manufacturer found two set screws had also backed out.The set screws were retightened in the screws during the revision surgery.This is report four of four for this event.
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