MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA GE MR/CT SKULL CLAMP; N/A

Catalog Number	A1117
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Increased Respiratory Rate (2486)
Date of Event	09/30/2025
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
A facility reported that the patient was positioned prone for the operation and a mayfield headrest (a1117) was applied.During the procedure, respiratory pressures increased, and upon review of the patient's positioning by the medical staff, it was observed that the head had slipped, causing a kinking of the endotracheal tube.The excessive angle caused difficulties with ventilation and maintaining gas exchange (risk of hypoxia and hypercapnia); therefore, the patient's head was repositioned.There were no adverse effects on the patient.
Additional Manufacturer Narrative
Updated field: d4, d9, g3, g6, h2, h3, h6.H11.The mayfield composite series skull clamp (a3059) was not returned and customer has advised that they will not be returning the unit; therefore, failure analysis cannot be completed.Device history record (dhr) review - product serial number information has not been provided; therefore, the device history record (dhr) could not be reviewed.The complaint description indicated that the skull clamp was used on a 3-year old patient.Additional precautions should be taken when using the skull clamp on children.An optional child¿s rocker arm is available for the skull clamp as are pediatric skull pins.Improper or suboptimal placement of the skull clamp can result in slippage or movement of the patient¿s head.The a1117 ifu provides the following warning: "mayfield skull clamp fixation devices are not recommended for use on children under five (5) years of age and extreme caution should be exercised in pediatric cases because of the thin skull." since the unit was not not returned for evaluation, the definite root cause cannot be identified.However, 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.
Event or Problem Description
N/a.

• Brand Name: GE MR/CT SKULL CLAMP
• Common Device Name: N/A
• 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: 23796592
• Report Number: 3004608878-2025-00231
• Device Sequence Number: 18759729
• Product Code: HBL
• UDI-Device Identifier: 10381780253600
• UDI-Public: 10381780253600
• Combination Product (Y/N): N
• PMA/510(K) Number: K081401
• 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): 02/03/2026

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: A1117
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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: 3 YR
• Patient Sex: Female