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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that during a posterior cervical fusion case, the rocker arm on the mayfield infinity skull clamp (a2114) moved while the patient's head was in place.The skull clamp was locking, but unlocked too easily.There was no surgical delay and no patient injury.Additional information received as follows: 1.When was the date of the incident? answer: before (b)(6) 2024.2.What action was taken after product problem occurred? answer: rep.Called, loaner received, (the loaner broke week ago friday (b)(6), bottom button doesn't lock) we do not have a replacement at this time.This is a problem.3.When was the product problem discovered (during inspection, before/during/after a procedure)? answer: clamp was locking, but unlocked too easily.Clamp was locked and secured with this patient, surgeon confirmed it to be safe to use for this patient, but wanted the c-clamp to be sent and checked on pressure, as it is on a patient to recreate the slipping of the locking system of the clamp.The lock is the one by the 2 skull pins.That piece was pushed in properly.
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.
Additional Manufacturer Narrative
The mayfield infinity skull clamp (a2114) was returned for evaluation: device history record (dhr) review - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - investigation of the returned unit showed that the right and left pawls are broken, the index knob is tight, and the 80lb torque knob is out of adjustment.The unit will be repaired with replacement of the set screw, label, right & left pawls, spacer and retaining ring, and general maintenance and cleaning will be performed.Conclusion - the complaint is confirmed via inspection of the unit.The probable root cause is rough 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.
Event or Problem Description
N/a.

• 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: 21074625
• Report Number: 3004608878-2024-00175
• Device Sequence Number: 6773777
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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