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

Catalog Number	11-3182
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been reported that a patient underwent a revision surgery on (b)(6) 2016 due to pseudarthrosis at the l5-s1 level and hardware failure at the l5-s1 level (another manufacturer's product).During this procedure, all of the other manufacturer's product was removed from all affected levels - t9 through the iliac crest - and replaced with the capsure ps system.Subsequently, in (b)(6) 2018, the patient reported feeling an "audible pop".Revision surgery was performed on (b)(6) 2018 due to pseudarthrosis and hardware failure.During this procedure it was noted that the rod was fractured on the right side of the construct between the l3 and l4 levels; multiple set screws were found loose.The surgeon removed and replaced the fractured rod and loose hardware.No complications were noted during this procedure.

• Brand Name: CAPSURE SPINE SYSTEM ROD
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 8066863
• Report Number: 3004638600-2018-00017
• Device Sequence Number: 11245007
• Product Code: NKB
• UDI-Device Identifier: 10840642104288
• UDI-Public: 10840642104288
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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 Catalogue Number: 11-3182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/13/2018
• 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
• Patient Age: 70 YR