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

Model Number	72-00-092810-00
Medical Device Problem Codes	Collapse (1099); Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event radiograph received notes the implant is now located posteriorly (intended to be placed mid-anterior.) no immediate post-operative radiographs were received.Original height and placement is unknown.Patient is asymptomatic and surgeon elects to leave device implanted.No patient injury is reported.No device was returned for evaluation as it remains in the patient.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-s1.Reportedly during routine follow up, the radiograph noted the implant at l4-l5 was now posterior from intended placement.Patient is asymptomatic.

• 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: 10103396
• Report Number: 3004893332-2020-00004
• Device Sequence Number: 13991440
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72-00-092810-00
• Device Catalogue Number: 72-00-092810-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1