MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ULTRA 360 PATIENT POSITIONING SYSTEM; N/A

Catalog Number A2009

Device Problem Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A facility reported that the ultra 360 patient positioning system (a2009) suddenly jolted and moved around while it was locked with a patient positioned in it.This occurred without the locking handle coming loose.No patient injury or surgical delay has been reported.

Manufacturer Narrative

The mayfield ultra 360 patient positioning system (a3059) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device found no device deficiencies that would have contributed to the reported complaint.Unrelated to the reported complaint, it was found that the unit was received without the standard or tri-star adaptor, and as a result, the unit had both handles readjusted to bring them back to within specifications.The shock cushions, adjustment wrench and finishing cap were replaced due to wear.All worn components were replaced with new parts, along with general maintenance and cleaning performed.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.Service & repairs could not duplicate slippage.Probable root cause is improper or suboptimal positioning of the patient in the mayfield system.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: ULTRA 360 PATIENT POSITIONING SYSTEM
• Type of Device: 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 ; 6099362319
• MDR Report Key: 15723183
• MDR Text Key: 307788876
• Report Number: 3004608878-2022-00228
• Device Sequence Number: 1
• Product Code: FWZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2009
• Device Lot Number: 171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1