MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA UNKNOWN MAYFIELD SKULL CLAMP; SKULLCLAMPS AND HEADREST SYSTEMS

Catalog Number XXX-MAYFIELD SKULL CLAMP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 12/09/2009

Event Type  Death  

Manufacturer Narrative

The mayfield device 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.There is no reported device failure by the complainant or in the medical records provided by the complainant.Based on the reported complaint information, the patient's demise is not related to the mayfield skull clamp.There are no contraindications for mayfield skull clamp use in patients that have sleep apnea.The contraindications for the mayfield skull clamp are included in the mayfield device instructions for use and are also discussed during training on the mayfield device.Additionally, consultation with our medical department confirmed that there are no known contraindications for use of the mayfield skull clamp on patients diagnosed with sleep apnea.Furthermore, as reported by the patient's mother, cause of death per death certificate was cardiopulmonary in nature, which she describes as "sudden death." she further clarified that the mayfield did not malfunction or presented with any issues at the time of the procedure; that a second procedure was even performed sometime later with a mayfield device.No further investigation is required.

Event Description

It was reported by a patient's mother that a mayfield skull clamp was used in a spinal procedure on a patient already diagnosed with sleep apnea, and the side effects ended badly and in "sudden death." the indication for use as described by patient's mother was "back pain (possibly cauda equina syndrome) and debilitating fatigue." additional information received indicates that the patient's cause of death on medical records is listed as cardiopulmonary death.The complainant has alleged no failure of the mayfield device used, but advised that a physician told her that the mayfield device is contraindicated in patients with sleep apnea.The complainant also provided further information from patient's medical records which states that one day post-operatively, the patient was found to have an increasing medium sized pectoralis muscle hematoma that was causing the brachial plexus neuritis which was resolving and patient was placed on decadron to assist with recovery.Patient was subsequently discharged from the facility on (b)(6) 2009.Complainant advises that the patient expired in (b)(6) 2014.

• Brand Name: UNKNOWN MAYFIELD SKULL CLAMP
• Type of Device: SKULLCLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 11853120
• MDR Text Key: 251613422
• Report Number: 3004608878-2021-00363
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-MAYFIELD SKULL CLAMP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49