MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY SUPPORT SYSTEM; N/A

Catalog Number	A1112
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
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 while the patient was being positioned in the mayfield infinity support system (a1112 for a chiari procedure, the surgeon stated that the ratcheting teeth were skipping.Though deliberate effort was made to ensure the clamp on both the left and right side was not too aggressive, the surgeon said he almost crushed the pediatric patient¿s head, but this was eventually prevented from occurring.Too much pounds of pressure was applied to the patient.This incident led to a 30-minute delay; however, the patient did not slip from the clamp and was not injured.Additional information received indicates that the "patient is ok.".
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The mayfield infinity support system (a1112) was not returned after three good faith attempts (gfes) were made; therefore, an evaluation of the device could not be performed and device history record (dhr) was unable to be reviewed.The root cause of the reported issue could not be determined.Based on the reported complaint, probable root cause includes damage to the unit and improper or suboptimal placement 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.

• Brand Name: MAYFIELD INFINITY SUPPORT SYSTEM
• Common Device Name: N/A
• 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 08540 ; 6099362319
• MDR Report Key: 19051003
• Report Number: 3004608878-2024-00044
• Device Sequence Number: 7354738
• Product Code: HBM
• UDI-Device Identifier: 10381780267720
• UDI-Public: 10381780267720
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• 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): 05/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: A1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 16 YR
• Patient Sex: Unknown
• Patient Weight: 122 KG