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
World neurosurgery (2020) published an article titled, "intraoperative head slippage with the head clamp system can occur during epileptic surgery." this is 2 of 3 reports for patient #1 of table 2 of the literature and linked to mfg report numbers 3004608878-2025-00084 and 3004608878-2025-00086: background - during neurosurgery, we use a head clamp system for firm head fixation.However, we have encountered slippage using the head clamp system, although this has not been adequately studied.In the present study, to increase the reliability of the analysis using a more homogeneous type of patient data, we conducted a prospective study of patients who had undergone epileptic surgery.We examined the potential risk factors for head slippage and postulated that the location of the pins might be important.Patients - the participants were japanese patients who had been treated from (b)(6) 2019 to (b)(6) 2020 at the comprehensive epilepsy center, seirei hamamatsu general hospital.Malfunction - head slippage had occurred in 3 of the 21 patients (14.3°/o; table 2).The distance between the preoperative and postoperative slipped pins was 2.5 mm.The slipped pins were the upper 2 pins but not the lowest pin in all 3 patients (table 2).However, no complications were associated with head slippage in these 3 patients.Conclusion - we should consider that head clamp slippage could occur intraoperatively.Https://doi.Org/10.1016/j.Wneu.2020.07.051.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.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.Based on the reported complaint, the 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.

• 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: 21975840
• Report Number: 3004608878-2025-00085
• Device Sequence Number: 7310352
• 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: Literature
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/07/2025
• 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: 19 YR
• Patient Sex: Male