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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON BALLAST SPINAL SYSTEM Back to Search Results
Catalog Number 25840018580
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); 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. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the patient presented with acute osteomyelitis of t10, t11 and t12. She underwent a surgery. On an unknown date, post-op, the alleged screw broke at s2-alar. Hence, the patient underwent a revision surgery and the broken screw was explanted. The patient also had difficulty walking due to lower extremities, multilevel non-unions, spins osteomyelitis.

 
Manufacturer Narrative

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

 
Event Description

The procedure was adult scoliosis correction.

 
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Brand NameCD HORIZON BALLAST SPINAL SYSTEM
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
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key9803598
MDR Text Key182537775
Report Number1030489-2020-00286
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK153442
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number25840018580
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 Received06/24/2020
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

Patient TREATMENT DATA
Date Received: 03/07/2020 Patient Sequence Number: 1
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