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

Catalog Number	9392225
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Devices of multiple part/lot numbers were implanted during the procedure including: part: 9402215 / lot: unk (x1) part: 9402204 / lot: unk (x1) although it is unknown if any of these devices contributed to the reported event, we are filing this mdr for notification purposes.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that patient with l4 burst fracture underwent one above and one below surgery at l3-5 in which spinal cages and screws was implanted.Post-op, spacer moved to the left side due to loosening of l3 screw.Patient complications were reported unknown.The patient¿s bone was significantly poor.There is no plan to conduct revision surgery.It was reported that patient had pain, but it is unknown if the incision or loosening has caused the pain.
Additional Manufacturer Narrative
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; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 6253001
• Report Number: 1030489-2017-00108
• Device Sequence Number: 16309859
• Product Code: MQP
• UDI-Device Identifier: 00613994676580
• UDI-Public: 00613994676580
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100976
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2016

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9392225
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: 12/21/2016
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 79 YR