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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 6642007
Device Problems Mechanical Problem (1384); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2022
Event Type  malfunction  
Event Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l4-s1 fusion with l5-s1plif for l4-5 stenosis. It was reported that bilateral screws were placed from l4-s1. When placing the rod, it wasn¿t able to get the rod to seat in the l5 screw. It was decided to break off the set screws at l4 and s1, and not place a set screw in the l5 screw. It was able to get the extender to release, but the extender was damaged in the process.  product will be returned. There were no patient symptoms or complications reported as a result of this event. Additional information received from manufacturer representative that surgeon wasn¿t able to get the rod to seat into the screw so he broke the tab off. He wasn¿t able to get the rod seated in the screw. Product came in contact with patient.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW 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
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key14460051
MDR Text Key292502258
Report Number1030489-2022-00478
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6642007
Device Catalogue Number6642007
Device Lot NumberKH18E001
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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