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

Catalog Number 108-L-6550C

Device Problems Fracture (1260); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 03/19/2024

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 338622530
• Report Number: 3004893332-2024-00005
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00840916131388
• UDI-Public: 00840916131388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191576
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 108-L-6550C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 63 YR
• Patient Sex: Male