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

Model Number	72-00-092810-00
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad, ca
• MDR Report Key: 10469129
• Report Number: 3004893332-2020-00007
• Device Sequence Number: 11581672
• Product Code: MAX
• UDI-Device Identifier: 00840916124618
• UDI-Public: 00840916124618
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention