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

Catalog Number	A1114
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An authorized distributor reported that while the mayfield infinity skull clamp system (a1114) was in place on a patient, it loosened 10 lbs.Of the 80 lbs.Torque screw resulting in minimal rotation of the patient's head.As a result, there was increased surgery time of 30 minutes.However, there was no injury, and the patient was placed under evaluation.End user facility name: (b)(6).
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a1114) is 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 was not confirmed as valid after evaluating the device.The inspection shows that the lock mechanism can be closed properly and has no movement when tested under pressure at 20, 40, 60, 70 and 80 lbs.It should be noted that the skull clamp should first be positioned and then closed and should not be moved after closing, as this will damage it.The torque screw and ratchet arm are working properly, but the skull clamp's base has worn off inner threads in the center of the starburst teeth.This prevents the adapter from being properly fixed; therefore, the base must be machined and tabbed to insert heli coil threads.To resolve the observed issue, the skull clamp base casting has been drilled and a new heli coil has been inserted.After completing the reassembly, including the adjustment, the skull clamp was subjected to a successful function test and it meets manufacturer specifications.Root cause - the complaint is not confirmed.The lock mechanism can be closed properly and has no movement when tested under pressure at 20, 40, 60, 70 and 80 lbs.The unit required replacement of worn parts from routine use and wear.No further corrective action is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, corrected field: h11 (root cause).Root cause - the complaint is not confirmed.The lock mechanism can be closed properly and has no movement when tested under pressure at 20, 40, 60, 70 and 80 lbs.The torque screw and ratchet arm are working properly, and the replacement of worn parts due to routine use and wear is unrelated to the torque screw.The probable root cause of this complaint of the torque screw loosening is improper or suboptimal placement of the unit.Additionally, inadequate placement of the skull clamp can result in movement of slippage of the patient.The a1114 ifu provides the warning, ¿failure to properly position patient and to fully secure all adjustment portions of this or any support device may result in serious patient injury.¿ the ifu also provides references for correct and incorrect positioning of the skull clamp.No further corrective action is required based on the acceptability of risk and no adverse trends were identified.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 INFINITY 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: 23917283
• Report Number: 3004608878-2025-00242
• Device Sequence Number: 9093241
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (Y/N): N
• PMA/510(K) Number: K051440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: A1114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2019
• 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 Sex: Unknown