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

Model Number	11-3000
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned for inspection were multiple items including set screws, pedicle screws and spinal rods.The individual item subject of this event was not identified.Visual inspection of the returned set screws found wear consistent with the reported use in a pedicle screw construct.The returned pedicle screws and spinal rods also exhibited signs of use and wear consistent with the reported event.Further evaluation found no functional defects and the production records did not identify any non-conformances to specifications for release.Based on the results of our investigation, a definitive conclusion could not be drawn.
Event or Problem Description
Approximately 6 months post-operatively, a patient reportedly experienced pain.A surgical procedure was performed at which time the surgeon identified a single set screw separated from one pedicle screw in the construct.The set screw and pedicle screw construct were replaced and the construct extended.

• Brand Name: CAPSURE SPINAL SYSTEM
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton, ct
• MDR Report Key: 9832611
• Report Number: 3004638600-2020-00002
• Device Sequence Number: 1766967
• Product Code: NKB
• UDI-Device Identifier: 10840642103953
• UDI-Public: 10840642103953
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K081228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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
• Device Lot Number: 661U095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/14/2020
• 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