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

Catalog Number	A2114
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield infinity xr2 skull clamp (a2114) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation of the returned unit showed that the unit had both the right and left pawls broken.The unit is over three years old and has no history of service.The 80lb torque knob is sticking, the index knob is loose and due to lack of service, it is recommended that the unit have a preventative maintenance (pm) service.Additionally, the unit was received without the black case or the pediatric rocker arm.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.New components were added to replace worn internal parts, and pm performed.Root cause - complaint confirmed via inspection.The unit has no service history and requires preventive maintenance and replacement of worn parts.Additionally, improper, or suboptimal placement of the skull clamp can contribute to movement of the patient¿s head.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
A facility reported that during spine surgery, a staff member was transferring the patient pinned in the mayfield infinity xr2 skull clamp (a2114) from the transport bed and when they attempted to turn the patient from supine to prone position, the plunger disengaged.This caused the patient's head to slip out of the pins resulting in a minor superficial laceration that did not require stitches.There were slight changes in the patient's vital signs as per neuro monitoring following the incident, prompting the anesthesiologist to request to abort the case.No surgical delay have been reported.Additional information received as follows: anesthesia ask to abort the case".Was the procedure cancelled, or was it rescheduled to another date? "i do not have any further information.All the information written on the paper is all i got.".

• 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
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18764502
• Report Number: 3004608878-2024-00022
• Device Sequence Number: 7739322
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/22/2024

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: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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
• Patient Sex: Unknown