MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.However, applicable imaging studies were returned to the manufacturer for evaluation, whose review is as follows: "l5-s1 construct screws show probable bilateral s1 screw breakage.A spondylolisthesis is present.There is no interbody graft.It is unknown what the degree of reduction of the spondylolisthesis was immediately post-op.An interbody graft may help with deformity reduction and fusion.Fusion status is unknown.Root cause indeterminate.".

Event Description

It was reported that the patient underwent spinal fusion from l5 to s1 due to spondylolisthesis (grade 1) / spinal stenosis.Post-op, on an unknown date, (after 3 months), both the s1 level screws were visibly broken at the 4th or 5th thread.Patient was currently doing physiotherapy.The screws were still inside the patient.Reportedly, the patient was overall doing fine.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• 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: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5694472
• MDR Text Key: 47649661
• Report Number: 1030489-2016-01616
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2016
• 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: 36 YR