On (b)(6) 2017, it was reported that the standard infinity skull clamp got stuck on the patient¿s head and had to be pried apart.Request for additional information was sent and on (b)(6) 2017, the following was provided by the customer: a (b)(6) -year-old female was undergoing an unknown procedure.It is unknown if the surgery was performed with a stereotaxy device.The action that was taken after the product problem occurred with the clamp was reported as ¿crawled under table and pried apart¿.Adult skull pins were used; the brand and lot number of skull pins were unknown.There was no patient injury or death alleged, and no revision/medical intervention was required.No delay in surgery due to product problem was reported.Patient outcome was ¿fine¿.The skull pins are not available to be returned for evaluation.
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