MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 7540020

Device Problems Difficult to Insert (1316); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 12/03/2014

Event Type  Injury  

Event Description

It was reported that a patient had severe leg pain due to bad placement of the s1 screws and therefore underwent a ¿revision of a stabilization at l3-s1, switched the s1 screws to iliac screws so that it became a l3-iliac fixation.It was reported that during surgery, it was not possible to fix the set screws into the screws.The set screws wouldn¿t fit well into the screws as well as into the connectors.During the surgery, the surgeon slipped with the screw driver from the screw and pierce through the abdomen and the set screw stayed in the abdomen.After the spine surgery was finished they turned the patient and turned it to pull the screw out of the abdomen.The patient is stable now.Due to the complication with the screw driver, the patient has abdominal pain.¿.

Manufacturer Narrative

(b)(4).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.

• Brand Name: CD HORIZON
• 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: 4364920
• MDR Text Key: 5117875
• Report Number: 1030489-2014-04853
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K052187
• 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: 12/03/2014

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: 7540020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/29/2014
• 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): Required Intervention
• Patient Age: 00080 YR