MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA; ROD

Model Number 158-3500-01A

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/27/2017

Event Type  Injury  

Event 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
• Type of Device: 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: 8070508
• MDR Text Key: 127129061
• Report Number: 1722511-2018-00036
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 00822409019915
• UDI-Public: (01)00822409019915(17)220106(10)A174272
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2022
• Device Model Number: 158-3500-01A
• Device Lot Number: A174272
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR