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

Model Number	P11351-508
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were not received to determine the initial placement or the degree of migration at the time of the event.Complaint cannot be confirmed.Returned device was disassembled and scratched as a result of the removal.The device meets specifications except for the missing rear screw that was not returned (lost) as a result of the removal.A mechanical malfunction or collapse is not apparent in the subject device.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 migration is unknown.
Event or Problem Description
On (b)(6) 2020 patient received an interbody device at l5-s1.Patient was asymptomatic for approximately 7 months post-operatively, when displayed localized pain in hip and buttock area.Reportedly upon evaluation, the device had migrated posteriorly.Radiographs were not received.Revision surgery was performed on (b)(6) 2021.

• Brand Name: LUCENT XP
• Common Device Name: INTERVERTEBRAL FUSION DEVICE- INSERTER ASSY
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 11935980
• Report Number: 3004893332-2021-00006
• Device Sequence Number: 4345203
• Product Code: MAX
• UDI-Device Identifier: 00840606114882
• UDI-Public: (01)00840606114882(10)193001(11)200615
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K182584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: P11351-508
• Device Catalogue Number: P11351-508
• Device Lot Number: 193001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/03/2021
• 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
• Patient Age: 74 YR