MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 25630018590

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X ray review results: post-op x-rays for thoraco-lumbar-sacral stabilization with pre revision x-ray.On the pre-revision x-rays there are fractured iliac screws bilaterally.Fusion status is unknown.The post revision x-ray, a fractured portion of the gearshift probe is seen in the iliac wing.This doesn't appeared to interfered with the placement of the revision screw.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was pre-operatively diagnosed with failed fusion and underwent screw placement surgery at s2- iliac levels.Post-operatively, the screws were broken at the shafts.As a result, revision surgery was performed to replace the product.The screw shaft of the broken product remained inside the patient.No patient symptoms or complications were reported as a result of this event.

• Brand Name: CD HORIZON BALLAST SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8287956
• MDR Text Key: 134439020
• Report Number: 1030489-2019-00091
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169412637
• UDI-Public: 00643169412637
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25630018590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR