MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD 3 POINT HEADREST; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Model Number A1059

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2023

Event Type  malfunction  

Event Description

Mayfield 3 point headrest.Tongs pulled out of service as they would not attach to holder on or (operating room) table."a-1059 integra sticker 115017.".

• Brand Name: MAYFIELD 3 POINT HEADREST
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION
• MDR Report Key: 17623868
• MDR Text Key: 322078262
• Report Number: MW5144945
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1059
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1