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

Catalog Number 11-1591

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

The explanted device was returned for evaluation and was visually examined.Damage was observed which is consistent with the reported removal.There is insufficient evidence to establish a root cause.

Event Description

Approximately two months post-operatively, the surgeon noted that the implant construct had migrated.A surgical procedure was performed at which time the implant was removed.

• Brand Name: STAXX XD
• Type of Device: INTERVERTEBRAL BODY REPLACEMENT DEVICE
• 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; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 9182776
• MDR Text Key: 162442329
• Report Number: 3004638600-2019-00011
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 10840642100198
• UDI-Public: 10840642100198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 11-1591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention