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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. CH HORIZON SPINAL SYSTEM

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MEDTRONIC SOFAMOR DANEK USA, INC. CH HORIZON SPINAL SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paralysis (1997); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative

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. Although it is unknown whether the reported product caused or contributed to the reported event, we are filling this mdr for notification purpose. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient had undergone a surgery at l6 due to ossification of the posterior longitudinal ligament. On an unknown date, post-op, patient had posterior junctional kyphosis. Allegedly, patient was also suffering with paralysis and could not walk steadily. As reported by the healthcare professional, paralysis was caused due to proximal junctional kyphosis. An additional surgery was performed in which fixation range was extended to c5 by performing fixation at c5-l3. There was prolongation of existing hospitalization due to paralysis.

 
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Brand NameCH HORIZON SPINAL SYSTEM
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis TN 38132
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK USA, INC.
1800 pyramid place
memphis TN 38132
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key9565726
MDR Text Key174283869
Report Number1030489-2020-00040
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received12/10/2019
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 Initial

Patient TREATMENT DATA
Date Received: 01/08/2020 Patient Sequence Number: 1
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