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

Model Number	A2009
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 3 reports linked to mfg report numbers: 3004608878-2022-00117 3004608878-2022-00121 a facility reported that the mayfield ultra 360 patient positioning system (a2009) slipped when patient's head was secured in it.No patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
The ultra 360 patient positioning system (a2009) 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 device showed that the reported complaint was confirmed from the evaluation.Unit received had the upper and lower handles adjusted to bring them back into tolerance from not holding properly.Both shock cushions, ¼ inch pin, and adjustment wrench were replaced from being worn.Unit also received with the standard adaptor and not the tri-star adaptor.Root cause - complaint confirmed via inspection of the unit.Both the upper and lower handles were not holding properly and required readjustment.Additionally, the unit required replacement of worn components.Root cause is routine use and wear of the device.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
• 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 ; 6099362319
• MDR Report Key: 14627728
• Report Number: 3004608878-2022-00118
• Device Sequence Number: 12031401
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/07/2022

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 Model Number: A2009
• Device Catalogue Number: A2009
• Device Lot Number: 134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2013
• 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