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

Model Number	108-ET-6550C
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photos and ct images confirmed the complaint.Patient retains explanted screws and no evaluation can be completed.Unknown factors include: patient activity at the time or prior to the event, patient bone quality, the degree of spinal instability, the longevity the degree of post lateral pseudarthrosis or 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) 2020 patient received bilateral posterior fixation from l2- s1.One year post operatively the patient felt pain.Ct depicted both screws at s1 were fractured and patient was revised on (b)(6) 2021 and both screws were replaced.Patient is asymptomatic post revision surgery.

• Brand Name: OVERWATCH
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINAL ELEMENTS, INC; 3115 melrose drive, suite 200; carlsbad CA 92010
• MDR Report Key: 12387963
• Report Number: 3004893332-2021-00010
• Device Sequence Number: 20056583
• Product Code: NKB
• UDI-Device Identifier: 00840916131876
• UDI-Public: (01)00840916131876(10)192477(11)200418
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K161842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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-6550C
• Device Catalogue Number: 108-ET-6550C
• Device Lot Number: 192477
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 108