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

Model Number A2114

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/01/2022

Event Type  malfunction  

Event Description

Sent to rep, waiting for final report.

• Brand Name: MAYFIELD
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 14573026
• MDR Text Key: 293150349
• Report Number: 14573026
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/12/2022,05/10/2022

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 Model Number: A2114
• Device Catalogue Number: A2114
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2022
• Date Report to Manufacturer: 06/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Male