MAUDE Adverse Event Report: SPINE WAVE, INC. TRUE POSITION SPACER; LUMBAR INTERVERTEBRAL FUSION DEVICE

Catalog Number 1208-01-2709

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Date 12/28/2023

Event Type  malfunction  

Event Description

During insertion of the implant, the device broke.The device was removed intra-operatively and replaced.

• Brand Name: TRUE POSITION SPACER
• Type of Device: LUMBAR INTERVERTEBRAL FUSION DEVICE
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise dr.; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 18580025
• MDR Text Key: 334841099
• Report Number: 3004638600-2024-00003
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 10840642107494
• UDI-Public: 10840642107494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1208-01-2709
• Device Lot Number: 024-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1