MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC T2 SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	9412500
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the fixed tab at the tip of the inserter has broken at the weld where it meets the shaft.This is a small weld that is typical of what is seen on other inserter¿s.The weld appears to have failed from force placed on it from positioning the cage.This is consistent with bend stress overload.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that intra-op, while using a mallet and angulated force to maneuver the implant into desired position, the fork tongs of the inserter were bent.The tongs were no longer able to retain and lock the implant.The procedure was however completed successfully with the same inserter.There were no patient complications as a result of this event.

• Brand Name: T2 SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 8787553
• Report Number: 1030489-2019-00763
• Device Sequence Number: 13870098
• Product Code: MQP
• UDI-Device Identifier: 00613994683557
• UDI-Public: 00613994683557
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2019

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: Health Professional
• Device Catalogue Number: 9412500
• Device Lot Number: CT13J038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1