MAUDE Adverse Event Report: SPINAL ELEMENTS, INC LOTUS; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	32545-30
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During the review of dhr, the record states that the product was inspected and accepted for use and met all specified parameters of the inspection process with no associated nonconformance specific to this product issue.The device was not returned as the patient retains the device, and could not be evaluated.Additionally, no images of the device or event radiographs were provided for analysis.Complaint cannot be confirmed.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the degree of pseudarthrosis (as reported), patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.) these factors dictate the longevity of the implant.Root cause or specific failure mode cannot be determined, but 3 years of cyclical fatigue on an unfused segment may have caused or contributed to this event.Labeling review notes: "possible adverse events.2.Disassembly, bending, and/or breakage of any or all of the components.3.Loss of fixation.".
Event or Problem Description
Received report from patient.Patient states he underwent 6 level posterior cervical thoracic fixation surgery at c2-t1 on (b)(6) 2019.Patient states he was cleared for normal activity.Reportedly t1 had not fused and the t1 screw fractured 3 years post-op.The device was removed/revised on (b)(6) 2023.On (b)(6) 2023 surgeon attempted a fusion surgery again t1-t2.And most recently the construct was extended four levels from t2-t6.Patient states he is currently doing well but endured pain.

• Brand Name: LOTUS
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• Manufacturer (Section G): SPINAL ELEMENTS; 3115 melrose dr; carlsbad CA 92010
• Manufacturer Contact: peter perhach ; 3115 melrose dr; carlsbad, CA 92010
• MDR Report Key: 19920140
• Report Number: 3004893332-2024-00007
• Device Sequence Number: 8094656
• Product Code: NKG
• UDI-Device Identifier: 00840606106917
• UDI-Public: 00840606106917
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K151705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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 Catalogue Number: 32545-30
• Device Lot Number: 170030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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