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

Model Number	108-ET-6540C
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Radiograph images confirmed the complaint.Though revision surgery occurred, pathology department would not release device, and the devices were not returned.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 but duration to failure could be a contributing factor.
Event or Problem Description
On (b)(6) 2021 patient received bilateral posterior fixation plf from l5- s1.Three month post operatively radiograph depicted both screws at s1 were fractured.Revision surgery was performed on (b)(6) 2021.

• 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 Contact: peter perhach ; 3115 melrose drive, suite 200; carlsbad, CA 92010 ; 7606071830
• MDR Report Key: 12763462
• Report Number: 3004893332-2021-00015
• Device Sequence Number: 3144917
• Product Code: NKB
• UDI-Device Identifier: 00840916131852
• UDI-Public: 00840916131852
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 11/05/2021

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: 108-ET-6540C
• Device Catalogue Number: 108-ET-6540C
• 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: 10/08/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 46 YR
• Patient Sex: Female