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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 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SOLERA VOYAGER SPINAL SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NAV6550005
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2019
Event Type  malfunction  
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 underwent minimally invasive transforaminal interbody lumbar fusion surgery due to spinal stenosis. Intra-op, tip of the driver was damaged. The product came in contact with the patient but no fragment of the broken instrument remained inside the patient. No patient complications were reported.
 
Manufacturer Narrative
Product analysis: the portion of the driver head that interfaces with the screw has been broken/sheared off. The face of the break is relatively flat with a slight angle. This is consistent with a driver tip that has been sheared off from overload. 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 DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key9435069
MDR Text Key184896094
Report Number1030489-2019-01397
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNAV6550005
Device Lot NumberCA17E010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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