MAUDE Adverse Event Report: WARSAW ORTHOPEDICS VERTEX RECONSTRUCTION SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number 7750445

Device Problem Disassembly (1168)

Patient Problem Pain (1994)

Event Date 03/20/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent a posterior thoracolumbar fusion t2-ilium.It was reported that the connector disengaged from the rod on the left side.The patient had an onset of pain and instability.The patient underwent a revision surgery to replace the rods and set screws bilaterally from t2-ilium and add two connectors per side.No additional patient complications were reported.

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): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• 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: 3757311
• MDR Text Key: 4469588
• Report Number: 1030489-2014-02222
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7750445
• Device Lot Number: 0203567W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2014
• 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): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 59