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

Model Number A1059

Patient Problem Insufficient Information (4580)

Event Date 08/08/2023

Event Type  Injury  

Event Description

This is a case about an elderly female who presented to hospital for a c3-c6 anterior and posterior cervical discectomy, fusion (acdf/pcdf: anterior cervical discectomy and fusion/posterior cervical discectomy and fusion), and laminectomy.The mayfield tong was applied, and the patient was sandwiched and flipped on the or (operating room) bed with no complications.At 2:55pm, it was reported that the mayfield tong system moved out of position.According to the surgeon, the mayfield tongs and cervical management system first slipped during exposure in the posterior portion of case.He scrubbed out, inspected the mayfield system, noticed no issues, and tightened everything again.Around the time when final instrumentation was being placed, the mayfield slipped again, prompting them to make more readjustments.There were a total of three slips.

• Brand Name: MAYFIELD
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 1100 campus road; princeton NJ 08540
• MDR Report Key: 17689246
• MDR Text Key: 322707760
• Report Number: 17689246
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A1059
• Device Catalogue Number: A1114
• Device Lot Number: 115009 OR 115909
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White