MAUDE Adverse Event Report: ORTHO SOLUTIONS UK LTD ULTOS GENERAL FUSION T PLATE 6 HOLE; Plate, fixation, bone

Model Number	OS422716-NS
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to ortho solutions directly from the patient that an x-ray confirmed a post-operative plate fracture 7 weeks after initial surgery.Subsequent revision surgery was required.

• Brand Name: ULTOS GENERAL FUSION T PLATE 6 HOLE
• Common Device Name: Plate, fixation, bone
• Manufacturer (Section D): ORTHO SOLUTIONS UK LTD; west station business park; spital road; maldon, essex CM9 6 FF; UK CM9 6FF
• Manufacturer (Section G): ORTHO SOLUTIONS UK LTD; west sation business park; spital road; maldon, essex CM9 6 FF; UK CM9 6FF
• Manufacturer Contact: jesin synthee ; unit 5 west station business park; spital road; maldon, essex CM9 6-FF ; UK CM9 6FF
• MDR Report Key: 17244165
• Report Number: 3008951116-2023-00002
• Device Sequence Number: 20510181
• Product Code: HRS
• UDI-Device Identifier: 05055662946512
• UDI-Public: 05055662946512
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K141784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: OS422716-NS
• Device Catalogue Number: OS422716-NS
• Device Lot Number: 2018001280/2018003122/41916B15
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2022
• Initial Report FDA Received Date: 07/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown