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

Catalog Number P11351-011

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 319922755
• Report Number: 3004893332-2023-00002
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00840606114868
• UDI-Public: 00840606114868
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: P11351-011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male