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

Catalog Number	11-1550
Medical Device Problem Codes	Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are attempting to obtain additional information regarding this event; should more information become available we will update the agency accordingly.
Event or Problem Description
The surgeon reported approximately 6 months post-operatively that the implant construct was separated and had migrated.The surgeon reported that this event may be related to a fall the patient experienced.
Additional Manufacturer Narrative
Follow-up 01 contains additional information updated regarding the identification, return and investigation findings of the subject device in fields b5, d4, d6b, h4 and h6 and change to event type to serious injury in fields b1, b2 and h1.
Event or Problem Description
A surgical procedure was performed to remove the implant.
Additional Manufacturer Narrative
Follow-up 02 to correct: d1 add registered trademark symbol to brand name.D4: correct 510(k) number.

• Brand Name: STAXX® XD SYSTEM
• 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; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; ste 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 18328807
• Report Number: 3004638600-2023-00013
• Device Sequence Number: 12545076
• Product Code: MQP
• UDI-Device Identifier: 10840642100686
• UDI-Public: 10840642100686
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 11-1550
• Device Lot Number: 741Y05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 11/14/2023; Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/11/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2023
• 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: Unknown