MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number G6957624

Device Problem Malposition of Device (2616)

Patient Problem Peroneal Nerve Palsy (2362)

Event Date 04/10/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterior cervical spinal surgery at c4-6 to treat a trauma injury.After the procedure was complete, it was found on x-ray that there may be a screw malpositioned.Ct angiography and revision surgery were performed to replace a screw at c4 left and remove another screw at c4 right, with continued general anesthesia from the initial surgery.It was also reported that the patient developed c5 palsy post-op.No additional information is available at this time.

Manufacturer Narrative

(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.

• Brand Name: VERTEX RECONSTRUCTION SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3801977
• MDR Text Key: 21875863
• Report Number: 1030489-2014-02451
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: G6957624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2014
• Initial Date FDA Received: 05/09/2014
• 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
• Treatment: SCREW, ROD
• Patient Outcome(s): Required Intervention