MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN MEDTRONIC IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported in an abstract that a total of 17 patients underwent oblique lumbar interbody fusion (olif).Hemiplegia (left leg) and anemia were observed in one out of 17 patients.The patient was treated by transfusion.Also, it was reported that the symptomatic nerve may be retracted during surgery.The hemiplegia (left leg) and anemia were observed having improved from 3 months after the olif with medication.

Manufacturer Narrative

The regulatory report is being submitted with information collected from the abstract titled, "simultaneous combined anterior and posterior lumber fusion with o-arm navigation", by author toshitada sawada, et.Al.The purpose: simultaneous combined anterior and posterior lumber fusion has been performed using oblique lumbar interbody fusion and percutaneous pedicle screw system with 0-arm navigation in our hospital.This is the report of its clinical short term results.(b)(4): neither the device nor applicable imaging films were returned to the manufacturer for evaluation; therefore, the cause of the event cannot be determined.

Manufacturer Narrative

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

• Brand Name: UNKNOWN MEDTRONIC IMPLANT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4256776
• MDR Text Key: 5048347
• Report Number: 1030489-2014-04410
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2014
• 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