MAUDE Adverse Event Report: TITAN SPINE, LLC ENDOSKELETON® TAS NANOLOCK 12MM, IMPLANT, LARGE; 12MM LARGE IMPLANT

Model Number	2307-0212-N
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A subject matter expert (sme) was contacted and provided the fluoroscopy images from the case.The sme reviewed the case and agrees with the performing surgeons.The sme stated "it appears to be a mechanical failure of the bone which resulted in the failure, and not related to the implant".A review of the device history record of the subject devices was completed.No anomalies or non-conformances were generated during the manufacture of these devices that would have led to this complaint condition.
Event or Problem Description
A revision from an endoskeleton® tas case from (b)(6)2017 was performed on (b)(6)2017.The revision was scheduled as it was determined the implant subsided into the vertebral body on l3-l4.The surgeons involved in the original case and the revision case concur that the implant did not result in the failure as the patient had unusually soft bone.

• Brand Name: ENDOSKELETON® TAS NANOLOCK 12MM, IMPLANT, LARGE
• Common Device Name: 12MM LARGE IMPLANT
• Manufacturer (Section D): TITAN SPINE, LLC; 6140 w. executive dr. ste a; mequon WI 53092
• MDR Report Key: 6799175
• Report Number: 3006340236-2017-00009
• Device Sequence Number: 19225215
• Product Code: OVD
• UDI-Device Identifier: 00191375013853
• UDI-Public: (01)00191375013853(11)170329(17)210927(10)TM0054441(240)23070212N
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K141953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2017

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 Expiration Date: 09/27/2021
• Device Model Number: 2307-0212-N
• Device Catalogue Number: 2307-0212-N
• Device Lot Number: TM0054441
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 08/16/2017
• 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: Hospitalization; Required Intervention