MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TL; 7 DEG LORDOTIC, IMPLANT, 18MMX50MMX8MM

Catalog Number	7107-0308
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records for the subject device was reviewed.The review revealed there were no anomalies or non-conformances generated during the manufacture of the product that would contribute to this complaint condition.Off label use due to different biologics utilized by the surgeon was reported.Attempts were made to receive the imaging (fluoroscopy, x-ray, ct) of the implant after initial surgery and prior to revision surgery were made.Images were not received; therefore, no investigation could be conducted.Device/imaging not received.
Event or Problem Description
The surgeon performed an open lateral view microscopic approach at lumbar 3-4 level that was adjacent to an existing fusion on (b)(6) 2016.This was a standalone procedure that was off label due to different biologics utilized by the surgeon.During a follow up, images showed the device had backed out 3-4mm from the disc space.The surgeon performed a revision surgery on (b)(6) 2016.The revision surgery was successfully completed to reposition the implant within the disc space.There was no adverse effect or harm to the patient due to implant backing out of the disc space.The patient is doing great after the revision surgery.

• Brand Name: ENDOSKELETON® TL
• Common Device Name: 7 DEG LORDOTIC, IMPLANT, 18MMX50MMX8MM
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6077399
• Report Number: 3006340236-2016-00010
• Device Sequence Number: 1136010
• Product Code: MAX
• UDI-Device Identifier: M682710703080
• UDI-Public: +M682710703080/$A150405/16D20150401O
• Combination Product (Y/N): N
• PMA/510(K) Number: K140055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2016

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
• Operator of Device: Physician
• Device Catalogue Number: 7107-0308
• Device Lot Number: A150405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 11/03/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 82