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

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

Patient Problems Neurological Deficit/Dysfunction (1982); No Code Available (3191)

Event Date 08/05/2010

Event Type  Injury  

Event Description

It was reported in a retrospective review of a consecutive series of 48 patients with thoracolumbar burst fracture treated with anterior corpectomy.Preoperative clinical and radiographic data of all cases were originally collected.Surgical indications were motor neurologic deficit and thoracolumbar column instability.48 consecutive patients with acute thoracolumbar burst fractures who were treated in an out unit with anterior decompression, titanic mesh autograft, and internal fi xation with a z-plate were evaluated.There were 30 male and 18 female patients in this group.The mean age was 39.2 years (range, 23¿52 years).The fracture levels were 6 t11, 20 t12, 18 l1, and 4 l2.Twenty-two patients (45.8%) with acute thoracolumbar burst fractures presented with a neurologic deficit.The postoperative recovery of neural function, restoration of anterior cortex collapse, kyphotic angle, and spinal canal compromise were observed.Three patients had a prolonged chest tube removal and no one developed infection.

Manufacturer Narrative

(b)(4).Location : hospital.A literature article by xu, j, et.Al titled anterior z-plate and titanic mesh fixation for acute burst thoracolumbar fracture in (spine 2011;36:e498¿e504).

• Brand Name: UNKNOWN MEDTRONIC TISSUE
• 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: 4301316
• MDR Text Key: 5270790
• Report Number: 1030489-2014-04671
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/05/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 12/05/2014
• Supplement Dates Manufacturer Received: 11/05/2014
• Supplement Dates FDA Received: 09/15/2017
• 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 Age: 00039 YR