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

Model Number A2114

Device Problems Disconnection (1171); Device Slipped (1584)

Patient Problem Laceration(s) (1946)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

During turning the patient to the prone position on the jackson table, the mayfield radiolucent headframe came unlocked.The pins that attached the headpiece to the patient's head came undone causing a laceration to the patient's head and the scrub tech's hand.Fortunately, the surgeon was supporting the patient's head during the occurrence, so no more injury was cased to the patient.This was after the headpiece had been sent out to the manufacturer a fourth time for repair.

• 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: 15665606
• MDR Text Key: 302343368
• Report Number: 15665606
• 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: 10/20/2022,10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2022
• 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: 25915 DA
• Patient Sex: Male