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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SOLERA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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WARSAW ORTHOPEDICS CD HORIZON SOLERA SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 6440530
Device Problem Mechanics Altered (2984)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
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. Delay for 2hrs in overall procedure time. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient who was implanted with a spinal product type for unknown indication. It was reported that when surgeon successfully performed a 2 level olif at l4/5 and l5/s1. Then the surgeon perform a single position posterior spinal fusion using solera voyager 4. 75 system with o2-oarm + s8 navigation guided for screw insertion. Surgeon inserted 6 screws very smooth using navigation guided. And then inserted the rod very smoothly. In the final stage he inserted the set screws as well. He break off 5 set screw successfully. However during the last set screw on the right side of the patient at l4 level, he couldn't break the set screw off. Hence he kept on turning the screw driver hoping that the set screw can engage on the rod and then break off. But it did not happen. He tried it for a very long time. Around 20 minutes still it can not break off the final set screw. Hence right side break off set screw and the pedicle screw was removed and new pedicle screw and new set screw were used. And finally surgeon was able to lock the set screw in place and perform final tightening and break off all set screw successfully. There was delay of 2hrs in overall procedure time. There were no patient symptoms or complications associated with this event.

 
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Brand NameCD HORIZON SOLERA SPINAL SYSTEM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer (Section G)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
Manufacturer Contact
david gustafson
1800 pyramid place
memphis, TN 38132
7635149628
MDR Report Key11617457
MDR Text Key243906180
Report Number1030489-2021-00447
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberK143375
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,Followup,Followup
Report Date 08/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number6440530
Device Catalogue Number6440530
Device LOT Number0808775W
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/21/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/25/2020
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: 04/06/2021 Patient Sequence Number: 1
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