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

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

An 8cm head laceration caused by three point mayfield device originally positioned by surgical team.Laceration on left side of head.Sutured at end of case using 3-0 biosin.Attending notified, charge nurse notified.Patients head slipped lower during case.Resident asked to secure head by fellow.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 17886647
• MDR Text Key: 325273600
• Report Number: MW5146670
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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 Age: 55 YR
• Patient Sex: Male
• Patient Weight: 55 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White