MAUDE Adverse Event Report: SPINE WAVE, INC. CAPSURE SPINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	11-3160
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
At approximately two months post-operatively, a surgical procedure was performed to replace a loose locking screw that had disassociated from an offset connector in a multi-level pedicle screw construct.One locking screw and one connector were removed and replaced.
Additional Manufacturer Narrative
The removed locking screw and concomitant offset connector were returned and evaluated.Visual inspection noted deformation consistent with the reported use and the removal technique.Functional evaluation found no functional issues with either returned unit.Review of production records identified no issues related to production or inspection that may be associated to the reported event.Based on the evaluation findings and the information available, the exact root cause of this event could not be established.

• Brand Name: CAPSURE SPINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise dr.; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 16702960
• Report Number: 3004638600-2023-00002
• Device Sequence Number: 5616777
• Product Code: MNI
• UDI-Device Identifier: 10840642104202
• UDI-Public: 10840642104202
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 11-3160
• Device Catalogue Number: 11-3160
• Device Lot Number: 664K38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2012
• 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 Sex: Unknown