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

Catalog Number	9402215
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Only 1 quantity of this product has malfunctioned.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent corpectomy procedure due to infection at l4-l5.Post-op, one of the implanted encaps became dislodged from the central body and caused the cage to shift which was identified during a localized x-ray scan.It was found that the encap on the bottom had detached which caused the cage to shift anteriorly becoming lodged in the detached encap.Patient was underwent a revision surgery for the replacement of the implants.
Additional Manufacturer Narrative
X-ray image review result: post-op x-ray for l4-5 corpectomy shows that endcap seperated from the cage.The provided image is magnified and it is not possible to ascertain if additional fixation via a lateral place on position pedicle screw was present.If information is provided in the future, a supplemental report will be issued.

• Brand Name: T2 ALTITUDE EXPANDABLE CORPECTOMY 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: 7356593
• Report Number: 1030489-2018-00423
• Device Sequence Number: 581169
• Product Code: MQP
• UDI-Device Identifier: 00613994676320
• UDI-Public: 00613994676320
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K100976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2018

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9402215
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/30/2018
• 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: Required Intervention
• Patient Age: 70 YR