MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION MAYFIELD SWIVEL ADAPTOR ; HOLDER, HEAD, NEUROSURGICAL

Model Number A1018

Device Problem Noise, Audible (3273)

Patient Problem Fall (1848)

Event Date 10/29/2019

Event Type  Injury  

Event Description

Pt was in the operating room for class i posterior fossa craniotomy.The pt was placed in mayfield fixation and as closure was occurring, a snap sound was heard and the pt fell off the right side of the table and his head and body fell on the floor.

• Brand Name: MAYFIELD SWIVEL ADAPTOR
• Type of Device: HOLDER, HEAD, NEUROSURGICAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; cincinnati OH
• MDR Report Key: 9362900
• MDR Text Key: 167781900
• Report Number: MW5091246
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A1018
• Device Catalogue Number: 41B171
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR