MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD TRIAD SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number	A1108
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mayfield triad skull clamp (a1108) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the inspection of the skull clamp shows the skull clamp has a sticking swivel lock assembly, and a residue buildup is present.For the adjustment of the lock assembly new components need to be added to replace worn internal parts, such as the floating ratchet for adjusting the locking mechanism, the worn spring, o-ring, bearing balls and washer.The small parts of the rocker arm (washers, nut and garder screw) must be replaced due to wear, the swivel base has damaged thread and must be replaced, and the wrench is missing and must be added.Root cause - the complaint is confirmed via inspection of the unit.The skull clamp had a sticking swivel lock assembly and a residue buildup present.The swivel base had damaged threads.Probable root cause is routine use and rough handling of the unit.No further investigation 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
This is 2 of 3 reports linked to mfg report numbers 3004608878-2025-00079 and 3004608878-2025-00081: a facility reported that once fixed, the mayfield triad skull clamp (a1108) was not stable.The problem was found on the patient under anesthesia, before the surgery.Since the patient could not give up this surgery, we minimized the movement of the headboard as much as possible, taking into account its imperfect stability for the entire duration of the surgery.There was no increased surgery time or patient injury.

• Brand Name: MAYFIELD TRIAD SKULL CLAMP
• Common Device Name: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 21901868
• Report Number: 3004608878-2025-00080
• Device Sequence Number: 11764498
• Product Code: HBL
• UDI-Device Identifier: 10381780253518
• UDI-Public: 10381780253518
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2025

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: A1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: A1018 MAYFIELD SWIVEL ADAPTOR; A2101 MAYFIELD ULTRA BASE UNIT
• Patient Sex: Unknown