MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR MAYFIELD HEAD-FRAME; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 08/27/2013

Event Type  malfunction  

Event Description

A medtronic representative reported that after the surgeon opened the skull flap during a tumor resection, there was a malfunction with the mayfield head-frame.The patient's head was slipping out of the skull pins causing an inaccuracy in relation to the reference frame for navigation.The surgeon immediately noticed the inaccuracy, however as the patient was still in the sterile field, they were unable to re-register with navigation.The patient was repositioned, re-pinned with a different mayfield, and the surgeon completed the surgery without navigation.There was no impact on the outcome of the patient.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MAYFIELD HEAD-FRAME
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR
• MDR Report Key: 17529152
• MDR Text Key: 321407196
• Report Number: MW5136081
• 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: Other
• Type of Report: Initial
• Report Date: 10/22/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1