MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL HORSESHOE HEADREST; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number	A1012
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Neck Stiffness (2434)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
This is 2 of 4 reports for the mayfield system linked to mfg report numbers: 3004608878-2025-00148, 3004608878-2025-00150, 3004608878-2025-00151.A facility reported that the mayfield swivel horseshoe headrest (a1012) needs to be checked as it got loose/became unlocked during surgery, resulting in whiplash for the patient.It is unclear if the event led to increased surgery time.No further information is available.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The mayfield swivel horseshoe headrest (a1012) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the customer's statement is confirmed as valid after evaluating the device.The inspection of the mayfield horseshoe a1012 with the serial number (b)(6) shows both the gel pads are broken in several places, and the slide bar has no movement, and the unit must undergo a function test and be marked with instance number.However, the thread and starburst teeth are in good working order.To resolve the issues, the gel pads were replaced and marked and the unit has been subjected to a successful functional check to meet manufacturer specifications.Root cause - the complaint is confirmed via inspection of the unit.The gel pads were broken in several places, and slide bar had no movement.The probable root cause is damage to the gel pads from rough or improper handling of the unit.No corrective action has been initiated for the same or similar issue.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD SWIVEL HORSESHOE HEADREST
• Common Device Name: SKULL CLAMPS AND HEADREST SYSTEMS
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22555441
• Report Number: 3004608878-2025-00149
• Device Sequence Number: 21257709
• Product Code: HBM
• UDI-Device Identifier: 10381780267461
• UDI-Public: 10381780267461
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A1012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown