MAUDE Adverse Event Report: SPINAL ELEMENTS, INC LUCENT XP; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	P11351-011
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiographs were not received to determine the initial placement or the degree of alleged migration at the time of the event.Complaint cannot be confirmed.The device was not returned and therefore could not be evaluated.Unknown factors include: patient activity at the time or prior to the event, the degree of spinal instability, patient compliance with postoperative care instructions, or if the patient sustained a fall/impact of any sort.The root cause of the alleged migration is unknown.
Event or Problem Description
On (b)(6)2023, during routing follow up it was report that an interboady cage at l4-l5 had allegedly migrated posteriorly.Patient was asymptomatic.Initial surgery date was not reported.Revision occurred (b)(6)2023 to remove the interbody, but no additional implants were reportedly placed.Radiographs were not received.

• Brand Name: LUCENT XP
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose drive; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 17410442
• Report Number: 3004893332-2023-00002
• Device Sequence Number: 7038313
• Product Code: MAX
• UDI-Device Identifier: 00840606114868
• UDI-Public: 00840606114868
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K182584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2023

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 Catalogue Number: P11351-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male