MAUDE Adverse Event Report: SPINAL ELEMENTS, INC OMEGA XP; INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY

Model Number 72-00-092810-00

Device Problems Mechanical Problem (1384); Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

Event radiograph received notes the implant was located posteriorly (intended to be placed mid-anterior.) no patient injury is reported.Patient is asymptomatic, but the implant was revised.Evaluation of the device noted no damage to device as a result of a collapse.Device met specifications.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, patient compliance with postoperative care instructions, or if the patient sustained a fall/impact of any sort.Root cause of the migration is unknown.

Event Description

On (b)(6) 2020, patient underwent a ollif procedure at l4-l5.Reportedly during routine follow up, the radiograph noted the implant at l4-l5 was now posterior from intended placement.Patient is asymptomatic.Implant was revised on (b)(6) 2020.

• Brand Name: OMEGA XP
• Type of Device: INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad, ca
• Manufacturer Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, ca ; 6071830
• MDR Report Key: 10469129
• MDR Text Key: 204866488
• Report Number: 3004893332-2020-00007
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00840916124618
• UDI-Public: 00840916124618
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

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
• Device Operator: Health Professional
• Device Model Number: 72-00-092810-00
• Device Catalogue Number: 72-00-092810-00
• Device Lot Number: 147140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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 Outcome(s): Required Intervention