MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number	A2114
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
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 rotational arm of the mayfield infinity xr2 skull clamp (a2114) broke/failed during posterior cervical fusion procedure, resulting in a scalp laceration to the patient.The case was delayed for 30 minutes as they looked for a replacement.Subsequently 2 medwatch forms (mw5163030 and mw516031) were received indicating the following: "radiolucent mayfield c-clamp cracked on double pin side while the patient was locked into levo head holder.Dr.Was holding the patients head as the clamp failed.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.Mayfield infinity xr2 skull clamp (a2114) was not returned after three good faith effort (gfe) attempts were made; therefore, an evaluation of the device could not be performed.However, lot number information has been provided; therefore, device history records (dhr) were reviewed and found no anomalies.The definite root cause cannot be identified as the device was not returned.Based on the reported complaint, probable root cause is improper or suboptimal positioning 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.
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a2114) was returned for evaluation: failure analysis: the investigation of the returned unit showed that the lock is experiencing some difficulties in turning to the locked position.The 80lb torque knob is sticking and needs to be disassembled and cleaned, and the pawls are showing signs of wear.Since the unit was involved in a patient injury, it was sent to quality engineering (qe) for further investigation.Qe confirmed the findings of the service & repair report and noted that the rocker arm shaft was broken and the lock had resistance to turn to the locked position.No additional device deficiencies were noted.To resolve the issues, by the completion of service, new components will be added to replace worn internal parts, and general maintenance and cleaning will be performed.Root cause: the complaint is confirmed via the investigation.The probable root cause is improper handling and routine wear of the unit.No further investigation 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.

• Brand Name: MAYFIELD INFINITY XR2 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: 21027326
• Report Number: 3004608878-2024-00169
• Device Sequence Number: 9046118
• Product Code: HBL
• UDI-Device Identifier: 10381780253761
• UDI-Public: 10381780253761
• Combination Product (Y/N): N
• PMA/510(K) Number: K130389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: 02/07/2025; 05/22/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/14/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2020
• 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: 63 YR
• Patient Sex: Unknown