MAUDE Adverse Event Report: SPINEOLOGY INC. ELITE EXPANDABLE INTERBODY FUSION DEVICE

Catalog Number	541-0008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Spineology does not recommend using a handle other than the intended torque limiting handle with the elite driver for implant expansion.Once the torque limit had been reached, the physician attempted to expand the device further which likely contributed to the failure of the expansion bolt.
Event or Problem Description
It was reported that following placement of the elite expandable device in the intervertebral disc space, the physician used the elite torque limiting handle with the elite driver to expand the device and reported hearing a click signaling that the torque limit had been reached.The physician removed the torque limiting handle from the elite driver and placed another handle on the elite driver and contributed to expand the implant.After several attempts, the driver shaft rotated with no force.Fluoroscopic imaging of the elite implant revealed that the expansion bolt had broken.The physician was able to remove the proximal end of the expansion bolt, however, the distal end remained engaged in the nose of the implant.The physician left the elite implant in place to complete the surgical procedure.

• Brand Name: ELITE EXPANDABLE INTERBODY FUSION DEVICE
• Common Device Name: INTERBODY FUSION DEVICE
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 3rd street n.; suite 600; st. paul MN 55128 5455
• MDR Report Key: 6567705
• Report Number: 2135156-2017-00006
• Device Sequence Number: 926063
• Product Code: MAX
• UDI-Device Identifier: M7405410008
• UDI-Public: M7405410008
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 541-0008
• Device Lot Number: S17143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2017
• Initial Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR