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

Model Number	11-3980
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was reported to fda as a sus voluntary event report (b)(4).Per the report, the patient underwent pseudoarthrosis revision.At first post op visit, was found to have hardware failure.Required surgical intervention for revision.Set screw was found loose.

• Brand Name: CAPSURE SPINAL SYSTEM
• Common Device Name: 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 drive; ste 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; ste 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 13809233
• Report Number: 3004638600-2022-00001
• Device Sequence Number: 4702039
• Product Code: MNH
• UDI-Device Identifier: 10840642105575
• UDI-Public: 10840642105575
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K081228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2022

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
• Device Model Number: 11-3980
• Device Catalogue Number: 11-3980
• 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: 02/24/2022
• Initial Report FDA Received Date: 03/18/2022
• 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 Sex: Unknown