MAUDE Adverse Event Report: SPINAL ELEMENTS, INC OVERWATCH; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	108-L-6550C
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent tlifspinal fusion surgery at l2-l5 on (b)(6) 2023.On (b)(6) 2024 it was reported that the right l5 bone screw was fractured.There is no plan to revise the patient.
Additional Manufacturer Narrative
There is no plan for revision surgery and the device remains in situ.The device was not returned and was not available for evaluation.Image confirming the event was received depicting the fracture at mid shank.Lot number was not provided.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the proud placement of the screw, the degree of pseudarthrosis, 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.

• Brand Name: OVERWATCH
• Common Device Name: THORACOLUMBOSACRAL PEDICLE 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: 18980377
• Report Number: 3004893332-2024-00005
• Device Sequence Number: 15095879
• Product Code: NKB
• UDI-Device Identifier: 00840916131388
• UDI-Public: 00840916131388
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K191576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/26/2024

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 Catalogue Number: 108-L-6550C
• 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: 03/19/2024
• Initial Report FDA Received Date: 03/26/2024
• 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
• Patient Age: 63 YR
• Patient Sex: Male