MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP A2000

Catalog Number	A2000
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mayfield skull clamp (a2000) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the reported complaint is confirmed as valid after evaluating the device.The inspection of the skull clamp shows the skull clamp has a loose swivel lock and a residue buildup is present, which does not guarantee proper fixation of the patient's skull.For the adjustment of the lock assembly new components need to be added to replace worn internal parts.The hex bushing must be replaced in order to adjust the lock assembly, the plunger assembly was loose, proper fixation of the ratchet arm is not possible, and the assembly must be adjusted.To resolve the issues, the hex bushing was replaced and the lock mechanism was adjusted; the plunger assembly adjusted, the screws were replaced, and the skull clamp was subjected to a successful function test to meet manufacturer specifications.Root cause - the complaint is confirmed via inspection of the unit.The clamp had a loose swivel lock with a residue buildup present, the plunger assembly was loose, the ratchet extension could not be fixed properly, and the unit needed cleaning and replacement of worn parts.The probable root cause is routine use and wear of the unit.No corrective action is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
A facility reported that the mayfield skull clamp (a2000) was reported to be loose when fastened to a patient during surgery.The device was in contact with the patient at the time of the event.No patient injury was reported.It is unknown whether the event resulted in an increase in surgical time.The procedure was completed without further reported complications.

• Brand Name: MAYFIELD 2000 SKULL CLAMP A2000
• 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: 25126413
• Report Number: 3004608878-2026-00052
• Device Sequence Number: 16125930
• Product Code: HBL
• UDI-Device Identifier: 10381780253655
• UDI-Public: 10381780253655
• Combination Product (Y/N): N
• PMA/510(K) Number: K932807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: A2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2025
• 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