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	Pain (1994)
Date of Event	07/29/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A spinal surgery was performed on (b)(6) 2019 fixing the spinal column from l2 to sai.On (b)(6) 2019, an x-ray confirmed that the left and right rods were broken at l4/5.A revision surgery was performed on (b)(6) 2019 to replace the rods.This is report two of two for the second of the two rods.

• Brand Name: PAGODA
• Common Device Name: SPINAL FUSION ROD
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• MDR Report Key: 10160294
• Report Number: 1722511-2020-00012
• Device Sequence Number: 11729298
• Product Code: NKB
• UDI-Device Identifier: 00822409019915
• UDI-Public: (01)00822409019915(17)230315(10)A191390
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2020

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: 03/15/2023
• Device Model Number: 158-3500-01A
• Device Lot Number: A191390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR