MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA; ROD

Model Number	158-3500-01A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient received l4 spinal fusion surgery on (b)(6) 2017.After the operation, the rod was broken.On (b)(6) 2017, the patient was revised and the rod was replaced.On (b)(6) 2017, the patient was reported to be recovering smoothly.

• Brand Name: PAGODA
• Common Device Name: ROD
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper UT 84020
• MDR Report Key: 8070508
• Report Number: 1722511-2018-00036
• Device Sequence Number: 16558601
• Product Code: MNH
• UDI-Device Identifier: 00822409019915
• UDI-Public: (01)00822409019915(17)220106(10)A174272
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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: 01/06/2022
• Device Model Number: 158-3500-01A
• Device Lot Number: A174272
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR