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

Model Number A1059

Patient Problem Laceration(s) (1946)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

Mayfield skull clamp was placed on patient.The torque knob was tightened to 40lbs of force and the locking mechanism was locked.Patient was then placed prone and positioned using gel rolls.When the head was flexed by way of the head clamp, the locking mechanism failed.The pin slipped on the patient's head, causing a 2" scalp laceration.If the pin would have slipped completely, the head would not have been supported, risking a high cervical injury.The scalp laceration was sutured after we returned the patient in the supine position the hospital bed.We attached another clamp and manipulated the head in the same way, with the same result.The second head clamp was removed and the remainder of the procedure was done with the head on a cerebellar headrest.The two devices involved were sn [redacted number] and [redacted number], but it¿s unknown which device was used first or second.

• 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: 18282128
• MDR Text Key: 329935146
• Report Number: 18282128
• 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: 11/28/2023,11/01/2023

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: A1059
• Device Catalogue Number: A1059
• 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: 11/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5475 DA
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Race: White