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

Model Number	11-3552
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported a pedicle screw was noted as broken on radiograph approximately 4 months post-implant following a posterior thoraco-lumbar fixation at levels t12 through l2.A reoperation was performed to replace the construct.It was reported that the patient may have had experienced a traumatic event.

• Brand Name: CAPSURE SPINE SYSTEM SCREW
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 302; shelton CT 06484
• MDR Report Key: 10734920
• Report Number: 3004638600-2018-00012
• Device Sequence Number: 17007028
• Product Code: NKB
• UDI-Device Identifier: 10840642104912
• UDI-Public: 10840642104912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111913
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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: 11-3552
• Device Catalogue Number: 11-3552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 10/26/2020
• 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