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

Model Number	11-3000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject product has been returned for evaluation.A follow-up report with results of the investigation shall be submitted upon completion.
Event or Problem Description
The surgeon reported that multiple set screws were loose in a multi-level pedicle screw construct approximately one year post-operatively.Additionally, the rod on one side was broken.A surgical procedure was performed to replace the affected set screws, screws and rod in the construct.

• Brand Name: CAPSURE PEDICLE SCREW SET SCREW
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 7857594
• Report Number: 3004638600-2018-00010
• Device Sequence Number: 3195594
• Product Code: NKB
• UDI-Device Identifier: 10840642103953
• UDI-Public: 10840642103953
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K081228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: 11-3000
• Device Catalogue Number: 11-3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 09/07/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male