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

Catalog Number	A1059
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) review - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned unit shows that the lock has rotational and lateral movement and a residue buildup is present.Since a patient injury was involved, the unit was sent to quality engineering (qe) for further investigation.Qe confirms the findings of the service team and noted that there was movement present in the lock and there was little resistance to move the lock between the lock/unlock positions.To resolve the issues, new components were added to replace worn internal parts.Root cause - the complaint is confirmed via inspection of the unit.The unit needed cleaning and 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 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 surgeon was performing a c7-t1 decompression and fusion with the patient in the prone position in the mayfield modified skull clamp (a1059), and at the end of the case, blood was noticed under the drape.The surgeon looked under the drape and accessed that the skull clamp had slipped which resulted in a small laceration that was closed with staples.The patient was reported as stable.

• Brand Name: MAYFIELD MODIFIED 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: 25262699
• Report Number: 3004608878-2026-00061
• Device Sequence Number: 10544956
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• Combination Product (Y/N): N
• PMA/510(K) Number: PRE-AMEND
• 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
• Report Date (Section B): 05/22/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 75 KG