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

Device Problems Failure To Adhere Or Bond (1031); Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 05/05/2015

Event Type  Injury  

Event Description

It was reported that approximately fifteen months post-operatively, a surgical procedure was performed to remove the staxx implant which had migrated and fixation screws (unknown mfg) which were loose.The surgeon reported a non-union at this operative level.The procedure was performed successfully.

Manufacturer Narrative

The device was not available for evaluation.

• Brand Name: STAXX XD
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): SPINE WAVE, INC.; shelton CT
• Manufacturer Contact: ronald smith ; 3 enterprise dr., ste. 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 4827923
• MDR Text Key: 5901584
• Report Number: 3004638600-2015-00004
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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