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

Model Number 11-3000

Device Problem Material Separation (1562)

Patient Problem Pain (1994)

Event Date 02/11/2020

Event Type  Injury  

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 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
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton, ct
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton, ct
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, ct ; 9449494
• MDR Report Key: 9832611
• MDR Text Key: 191744830
• Report Number: 3004638600-2020-00002
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10840642103953
• UDI-Public: 10840642103953
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention