MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number	A2114
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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
Therapeutics and clinical risk management (2020:16) published an article titled: "estimation of risk factors for head slippage using a head clamp system.A retrospective study".This report is for patient #1 of 3 (male, age 59, underwent transnasal tumor removal) and linked to mfg report numbers 3004608878-2025-00069 and 3004608878-2025-00070: background - although complications have been associated with head clamp systems, few reports have described head slippage.The present study aimed to determine risk factors for head slippage and speculated that the position of head holder pins might be associated.Summary - in a prospective, cross-sectional, nonrandomized study by sakakura et al (2020),16 the objective of the study was to compare the location of pins pre- and postoperatively on ct images in cases of head slippage.Ct images were obtained with a radiolucent carbon mayfield 3-pin head holder (infinity xr2 radiolucent system).Twenty-one patients were included (mean age at surgery: 21±12.81 years; sex: 15 males, six females).Indications for surgery included electrode implantation (61.9%), epileptic focus resection (23.8%), and epileptic disconnection (14.3%).Head slippage was observed in three patients (14%).The center point between the most caudal pin and the most cranial pin was significantly associated with the occurrence of head slippage (p=0.014).The distance between the preoperative and postoperative slipped pins was 2.5 mm.The slipped pins were the upper two pins in all three patients.No complications were associated with head slippage.Malfunction - head slippage was observed in three patients (14%).The center point between the most caudal pin and the most cranial pin was significantly associated with the occurrence of head slippage (p=0.014).The distance between the preoperative and postoperative slipped pins was 2.5 mm.The slipped pins were the upper two pins in all three patients.No complications were associated with head slippage.Conclusion - clamped heads can slip during surgical procedures.We found that one head pin should be located within 4.5 cm from the nasion-inion (ni) line to avoid head slippage.
Additional Manufacturer Narrative
The mayfield infinity xr2 clamp (a2114) was not returned, and no specific device was identified, therefore, failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Additionally, the lot/serial number has not been provided to perform a device history record (dhr) review.As a result, the definite root cause cannot be identified.Of the cases reviewed, head slippage occurred in 3 of 28 cases or 10.7%, and slippage is a known risk associated with the use of the mayfield skull clamps.Based on the reported complaint, probable root cause is improper or suboptimal placement of the skull clamp on the patient.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Common Device Name: MAYFIELD
• 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: 21891389
• Report Number: 3004608878-2025-00062
• Device Sequence Number: 8146803
• Product Code: HBL
• UDI-Device Identifier: 10381780253761
• UDI-Public: 10381780253761
• Combination Product (Y/N): N
• PMA/510(K) Number: K130389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 59 YR
• Patient Sex: Male