MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP. MAYFIELD INFINITY SKULL CLAMP; NEUROLOGICAL HEAD HOLDER

Device Problems Device Slipped (1584); Output Problem (3005)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 05/21/2021

Event Type  Injury  

Event Description

Patient's head slipped in mayfield head pins.Mayfield with skull pins was applied to patient's head, then patient was positioned prone on wilson frame on or bed and shoulders taped torse foot of bed.While doing x-ray to check for position, surgeon noticed that the skull pin on left temporal had moved and was bleeding.Patient put back on stretcher.Mayfield removed and skin staples applied to laceration.A second laceration was also noticed that was also closed with staples.During positioning (prior to incision), mayfield head positioner slipped (ratchets loosened and was unrecognized).Patients head slipped out of pegs and sustained 2 lacerations in scalp requiring stapling.Manufacturer response for mayfield headrest, (brand not provided) (per site reporter).The screws were stripped.Device taken out of service permanently.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• Type of Device: NEUROLOGICAL HEAD HOLDER
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP.; 1100 campus rd; princeton NJ 08540
• MDR Report Key: 12655998
• MDR Text Key: 277128892
• Report Number: 12655998
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 22630 DA
• Patient Weight: 94