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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 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SOLERA VOYAGER SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 6642007
Device Problems Use of Device Problem (1670); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  malfunction  
Manufacturer Narrative
Evaluation of the returned device was not completed at the time of this report. A follow up report will be sent when analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via field representative regarding a patient who undergone spinal therapy with an indication of lumbar spinal canal stenosis. It was reported that during olif+pps procedure the instrument was shipped from (b)(6) for the operation of (b)(6). The instrument was used for continuous diversion on (b)(6). The sales rep attended the operation remotely on (b)(6) and did not attend the operation on (b)(6). They tried to attach the screw to the tab extender in the operation on (b)(6) but failed. When checked the tab extender, the screw tab for the previous operation was still attached to the tab extender. Since 8units (4 screws) could be used without any problem, operation was completed. The person in charge and the distributer did not notice that the tab remained, so they diverted the product in the operation as it was. The orthopedic nurse leader confirmed with the nurse in charge that the tab had not been removed. There was no delay in overall procedure time. No patient symptoms or complications as a result of this event. Levels implanted l4/5. Product used correctly according to the directions given in the ifu/labeling. There was no device breakage. It was reported that five sv47 tab extenters were returned. Deformation was found at screw tab connection and cap connection faces. Screw tab was not returned.
 
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Brand NameCD HORIZON SOLERA VOYAGER SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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 Key11722515
MDR Text Key252391724
Report Number1030489-2021-00523
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K143375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6642007
Device Catalogue Number6642007
Device Lot NumberCT15K075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/12/2015
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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