MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ULTRA 360 PATIENT POSITIONING SYSTEM; BASE UNITS AND ADAPTERS

Catalog Number	A2009
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the mayfield ultra 360 patient positioning system (a2009) does not hold position.The issue was detected during the intervention, but the procedure concluded regularly, and the surgery was performed with the same device, since they noticed the defect almost at the end of the surgery.There was no increased surgery time and no patient 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.
Additional Manufacturer Narrative
The mayfield ultra 360 patient positioning system (a2009) was returned for evaluation: failure analysis - the customer's statement was confirmed as valid after evaluating the device.The unit does not offer a stable hold and is loose.The handle assemblies shock cushions have migrated out of their position in the casting and block the gold handles from closing properly, and the cam rod and the adjustment nut of the lower handle must be replaced.The threads no longer work properly; the spring inside both handles and the cam support pins will be replaced; the small parts of the side plate assembly (balls, springs) must be replaced; the screws have limescale on them and need to be acidified; and the nylon washer and retaining ring of the standard adapter are missing; the torque screw shows damaged thread.The adapter shows deep scratches on the bearing surface on its bottom, and must be replaced to prevent damaging and disrupting the function of the handle.To resolve the issues, the cam rod and adjustment nut of the lower handle were replaced, the side plate assembly was overhauled, the standard adapter was replaced and marked, the base handle assembly¿s shock cushion and its cam link support pin were replaced and the handle assembly was reassembled and adjusted to build up the required pressure onto the transitional member.After completing the repair, the unit successfully passed a function test.Root cause - the complaint is confirmed via inspection of the unit.The unit was loose and unable to hold stably.The probable root cause is routine use and wear and lack or preventive maintenance.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.

• Brand Name: ULTRA 360 PATIENT POSITIONING SYSTEM
• Common Device Name: BASE UNITS AND ADAPTERS
• 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: 21322837
• Report Number: 3004608878-2025-00013
• Device Sequence Number: 15486085
• Product Code: FWZ
• UDI-Device Identifier: 10381780267850
• UDI-Public: 10381780267850
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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: A2009
• 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: 01/10/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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