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

Model Number A2114

Device Problem Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 11/11/2019

Event Type  malfunction  

Event Description

Patient was in prone position.Dr holding head until the head was positioned and locked into place.The head holder slipped causing lacerations to the patient's head.Sutures were placed to close lacerations.

• Brand Name: MAYFIELD
• Type of Device: HOLDER, HEAD, NEUROSURGICAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 311 enterprise dr; plainsboro NJ 08536
• MDR Report Key: 9362243
• MDR Text Key: 167585428
• Report Number: 9362243
• 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: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A2114
• 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: 11/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA