The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report numbers 3004608878-2020-00514, 3004608878-2020-00515, and 3004608878-2020-00517.
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This is 3 of 4 reports.A patient safety analyst reported that since the fall of 2019 there have been four (4) scalp lacerations as a result of the mayfield headrest.One required staples to repair and others required manual pressure with bacitracin.Additional information received on 04sep2020 indicating that while draping the patient to start of the cervical laminectomy with posterior spinal fusion procedure, positioned prone in the mayfield headrest, the (b)(6) male patient coughed and slipped out of the head pins causing a scalp laceration.The patient was repositioned and the mayfield headrest was removed and new pins and headrest were applied.The laceration was stapled and dressed.The patient's condition post procedure was reported as stable.
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Unique device identifier (udi): (b)(4).Mayfield skull clamp was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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