MAUDE Adverse Event Report: SPINE WAVE, INC. STAXX XD; INTERVERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	11-1590
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the device was implanted, evaluation could not be performed.The delivery instrument was returned; inspection found no abnormalities.
Event or Problem Description
Intraoperatively, the surgeon reported noting that the second implant in a bilateral construct appeared to be disconnected after placement.As the implant was secure, no further action was taken and the procedure was completed.

• Brand Name: STAXX XD
• Common Device Name: INTERVERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 9419553
• Report Number: 3004638600-2019-00014
• Device Sequence Number: 2738734
• Product Code: MQP
• UDI-Device Identifier: 10840642100167
• UDI-Public: 10840642100167
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K142996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/20/2023
• Device Catalogue Number: 11-1590
• Device Lot Number: 273U10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1