MAUDE Adverse Event Report: SPINE WAVE, INC. STAXX XD; SPINAL VERTEBRAL BODY REPLACEMENT

Catalog Number	11-1550
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
At an unspecified time post-operatively, the surgeon noted that the implant construct had separated.A surgical procedure was performed to remove the construct.

• Brand Name: STAXX XD
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 7844105
• Report Number: 3004638600-2018-00014
• Device Sequence Number: 1445010
• Product Code: MQP
• UDI-Device Identifier: 10840642100686
• UDI-Public: 10840642100686
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K102682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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 Expiration Date: 01/26/2022
• Device Catalogue Number: 11-1550
• Device Lot Number: 741T07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/04/2018
• 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