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

Catalog Number 9392225

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 12/21/2016

Event Type  Injury  

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 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: T2 ALTITUDE EXPANDABLE CORPECTOMY SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6253001
• MDR Text Key: 64885986
• Report Number: 1030489-2017-00108
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00613994676580
• UDI-Public: 00613994676580
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100976
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 9392225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: 12/21/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR