MAUDE Adverse Event Report: ORTHO DEVELOPMENT PAGODA; PEDICLE SCREW

Model Number 752-0004A

Device Problem Use of Device Problem (1670)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/30/2020

Event Type  Injury  

Event Description

Patient underwent surgery for a lumbar compression fracture on (b)(6) 2020.When applying final torque to the right set screw at l4, it would not tighten as it had been cross threaded.The set screw was replaced and final torque was applied.The surgeon reported that the patient's health was damaged because of the increased physical burden when the operation time was prolonged.

Manufacturer Narrative

Pictures of the set screw taken at the time of the event were provided showing contact marks on the bottom of the set screw consistent with using the screw to reduce the spinal rod which is a known issue that can lead to cross threading.

• Brand Name: PAGODA
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): ORTHO DEVELOPMENT; 12187 s. business park drive; draper, ut
• MDR Report Key: 10083227
• MDR Text Key: 191854875
• Report Number: 1722511-2020-00003
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K142146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 752-0004A
• Device Lot Number: A222575
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1