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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM Back to Search Results
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.

 
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Brand NameCD 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 Key5694472
MDR Text Key47649661
Report Number1030489-2016-01616
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/02/2016
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2016
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

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