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

Catalog Number 108-ET-654XC

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

Patient Problem Failure of Implant (1924)

Event Date 04/29/2021

Event Type  Injury  

Event Description

As part of a retrospective review presentation spanning 2019-2021 given by an orthopedic medical group, it was noted that a patient received a plf with bilateral posterior fixation from l5- s1 on (b)(6) 2021.Three months post operatively the s1 bone screw had fractured.Revision surgery was performed on (b)(6) 2021 to replace the screws will larger diameter screws.

Manufacturer Narrative

Though revision surgery occurred, the device was not returned.Device is not available for evaluation.Additionally, no event radiographs nor images of the device were provided for analysis.To date, multiple communication attempts have been made to retrieve the product information and lot number.Part number and lot number were not provided.Dhr review cannot be completed at this time.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, patient compliance with post-operative care instructions or if the patient sustained a fall/impact of any sort (no trauma was reported.).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 Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 12801095
• MDR Text Key: 282967834
• Report Number: 3004893332-2021-00017
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161842
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 108-ET-654XC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• 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 Age: 24 YR
• Patient Sex: Male