MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD COMPOSITE SERIES SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Catalog Number A3059

Patient Problems Spinal Cord Injury (2432); Hyperextension (4523); Intervertebral Disc Compression or Protrusion (4524)

Event Date 10/18/2023

Event Type  Injury  

Event Description

The pt was brought to the operating room for a posterior cervical surgery with decompression and fusion of the cervical spine due to severe spinal cord compression and myelomalacia.The pt was intubated by anesthesia.The surgeon had placed a mayfield clamp on the pt's head and the pt was turned prone onto the surgical table.As the mayfield clamp was attached to the table mount, the mechanism on the mayfield clamp broke and resulted ina hyperextension position which the surgeon quickly reduced into a flexion position.The pt's head was manually held by the surgeon while the mayfield clamp was removed.Afterwards the pt was turned to supine and back onto the gurney and a cervical collar was placed on the pt.The surgery was canceled, the pt was woken from anesthesia, his neurological status was assessed and no spinal cord injury was incurred.The surgery was rescheduled.Cervical disc disorder with myelopathy and c3/4 anterolisthesis with spinal cord compression.Pt admitted for posterior cervical decompression and fusion.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 18085212
• MDR Text Key: 327697373
• Report Number: MW5147852
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Ethnicity: Hispanic
• Patient Race: White