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This is 2 of 2 reports linked to mfg report number 3004608878-2022-00091: a facility reported that the mayfield skull clamp a3059 slipped during craniotomy.Subsequently, medwatch uf/ importer report # (b)(4) was received with the following information: "patient scheduled for suboccipital craniotomy for tumor resection (posterior/prone approach).Patient induced, invasive lines placed, then mayfield skull clamp applied by surgeon.Patient then positioned on or table, mayfield skull clamp attached to mayfield base (on or table) by surgeon and or registered nurse (rn).Registration for intraoperative mri scan navigation performed, patient's hair clipped, then surgical site prepped and draped.Surgery underway, surgeon had turned bone flap, and began applying dermahooks.To retract muscle greenberb c-clamp attached to mayfield skull clamp when mayfield skull clamp moved, causing patient's head to move during the procedure.Surgeon, with the help of or rn, attempted to reposition patient's head and neck position, but not successful.Surgeon closed surgical wound emergently, patient undraped.Then a different mayfield skull clamp applied by surgeon, then attached to different mayfield base.Patient's scalp assessed for lacerations caused by mayfield pins.And closed with staples.Patient then re-prepped, and re-draped, surgery continued, and completed without further incident.At completion of procedure, patient 's scalp reassessed, and bleeding from 2 inch laceration had ceased.Patient's hair washed with shampoo to remove blood from surgery and from laceration.Original intended procedure: suboccipital craniotomy for tumor resection" additional information received: was the surgery performed with a stereotaxy device? if yes, what type of stereotaxy equipment was used (manufacturer and model number)? the surgery was performed using medtronic stealth's articulating vertek arm #pn9734252 and cranial reference frame #pn961-337.How was the patient initially positioned for the surgery? was the patient repositioned at any time during the surgery? if yes, explain how the patient¿s position had changed after initial positioning had been completed? the patient was positioned prone on a skytron 3600b operating room table, with large gel rolls x2 for torso.Patient's head and neck were aligned midline, and in flexion for suboccipital approach.The patient remained in prone position during the entire time.The surgeon and or team worked together to remove the integra mayfield 2 base and composite skull clamp, and then placed a different integra mayfield (silver) base and skull clamp.What was the length of time the product was in use before the event occurred? patient had been prone in skull clamp for 45- 60 minutes prior to the event.Was there a delay of surgery over 30 minutes? yes, i estimate that the time was roughly 30- 45 minutes from closure of incision, removal of drapes, removal of original mayfield skull clamp setup, to placement of different mayfield skull clamp setup, re-prep of surgical site, draping of surgical site, then resuming of surgery.How much pounds of pressure was applied? surgeon states 60 lbs.Was there a revision/medical intervention required? procedure had to be , but patient had 3 scalp lacerations from skull pins which had to be sutured.
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