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

Model Number A2003

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

Patient Problem Laceration(s) (1946)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

A patient sustained a 3-inch laceration during a surgery to the front upper left side of the head from one of the mayfield pins.This occurred while repositioning the patient from supine to prone using the radiolucent mayfield headrest.

• Brand Name: MAYFIELD®
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 4900 charlemar drive; building a; cincinnati OH 45227
• MDR Report Key: 9744388
• MDR Text Key: 180610730
• Report Number: 9744388
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2003
• Device Catalogue Number: C10004834
• Device Lot Number: 4-37-C-1073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other