MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA; SPINAL FUSION ROD

Model Number	158-3500-01A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A spinal surgery was performed on (b)(6) 2021 fixing the spinal column with bilateral rods from t8 to l3 with one vertebra skipped due to tuberculous pyrogenic spondylitis.Bone fusion was difficult due to the infection.Subsequently, both rods broke.On (b)(6) 2022, a revision surgery was performed to replace the rods.The surgeon noted that there was no loosening of the screws and the rods were heavily loaded.

• Brand Name: PAGODA
• Common Device Name: SPINAL FUSION ROD
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer (Section G): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• Manufacturer Contact: drew weaver ; 12187 s. business park drive; draper, UT 84020 ; 8015539991
• MDR Report Key: 16174575
• Report Number: 1722511-2023-00001
• Device Sequence Number: 11345775
• Product Code: NKB
• UDI-Device Identifier: 00822409019915
• UDI-Public: (01)00822409019915(17)250505(10)A235951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2023

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 Expiration Date: 05/05/2025
• Device Model Number: 158-3500-01A
• Device Lot Number: A235951
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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
• Patient Age: 73 YR
• Patient Sex: Female