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

Model Number	11-1179
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a surgical procedure was performed approximately one month after an initial surgery at which time implanted devices were removed due to "failure".A subsequent surgery was performed approximately one month later to remove implanted devices again due to "failure".The implants included the manufacturer's device and another manufacturer's devices.
Additional Manufacturer Narrative
Follow-up #1 - receipt of additional information updated herein including section d4- catalog #, lot #, expiration date, unique identifier and section h4 - device manufacture date.Corrected information in section g4 - 510(k) number based on new information.

• 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
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise drive; ste 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; ste 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 14347434
• Report Number: 3004638600-2022-00002
• Device Sequence Number: 4907355
• Product Code: MQP
• UDI-Device Identifier: 10840642100525
• UDI-Public: 10840642100525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111418
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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: 11/27/2023
• Device Model Number: 11-1179
• Device Catalogue Number: 11-1179
• Device Lot Number: 744U12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female