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

Model Number	72-02
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly the fluoro and radiographs could not confirm the fragment remains in the patient.It also could not be confirmed that the fragment was removed via suction.The returned device was evaluated, and the prong was fractured off the inserter.Device met specifications except in the area of damage which could not be measured.The use of the detached inserter to impact the cage likely resulted in the prong of the inserter to fracture off.Root cause of the detachment of the inserter from implant is unknown.
Event or Problem Description
On (b)(6) 2020, patient underwent a ollif procedure at l4-s1.Reportedly during the procedure the inserter dislodged from the implant cage at l5-s1.Then the surgeon had to impact the inserter to advance the implant, causing the prong to fracture off the inserter.The fragment could not be seen on fluoro or radiograph, but also could not be confirm to be suctioned from the surgical site.There was no injury to patient.It is unknown if the fragment remains in the patient.

• 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: 9998101
• Report Number: 3004893332-2020-00002
• Device Sequence Number: 16780801
• Product Code: MAX
• UDI-Device Identifier: 00840916142193
• UDI-Public: 00840916142193
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 72-02
• Device Catalogue Number: 72-02
• Device Lot Number: 182-15064-R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1