MAUDE Adverse Event Report: SPINEOLOGY, INC. ELITE EXPANDABLE INTERBODY FUSION DEVICE; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 541-0002

Device Problem Material Separation (1562)

Patient Problem Pain (1994)

Event Date 06/18/2019

Event Type  malfunction  

Manufacturer Narrative

The cause of the bolt fracture could not be determined with the available information.

Event Description

The patient underwent a two level (l3-l5) lumbar interbody fusion surgery with placement of two elite expandable devices in (b)(6) of 2019.Approximately three months post-surgery, the patient reportedly was bending over and heard a "pop or crack" with immediate onset of new le symptoms.The patient returned for medical attention, was given an epidural steroid injection, and imaging confirmed that one of the implants had collapsed and that its bolt was not in the expanded position.The second implant appeared as expected with no concerns noted.In (b)(6) of 2019 a revision surgery was performed using the same plif approach and the bolt was found to be fractured and was removed.Given the ventral positioning of the implant in the tight disc space and no obvious evidence of gross instability, the surgeon made the decision to leave the implant in the disc space.

• Brand Name: ELITE EXPANDABLE INTERBODY FUSION DEVICE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): SPINEOLOGY, INC.; 7800 3rd street n.; suite 600; saint paul MN 55128 5455
• Manufacturer (Section G): SPINEOLOGY, INC.; 7800 3rd street n.; suite 600; saint paul MN 55128 5455
• Manufacturer Contact: andrew adams ; 7800 3rd street n.; suite 600; saint paul, MN 55128-5455 ; 6512568500
• MDR Report Key: 8800182
• MDR Text Key: 203663236
• Report Number: 2135156-2019-00005
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 541-0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 06/18/2019
• 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): Other
• Patient Age: 51 YR