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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
Catalog Number 6440530
Device Problems Metal Shedding Debris (1804); Device Operational Issue (2914)
Patient Problem Pain (1994)
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. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes. If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that on an unknown date, post-op, patient presented to surgeon with pain. Bone scan completed and showed hot spots at l3 and s1. Surgeon decided to reoperate and replace the set screw in revision surgery. During removal surgeon noticed a large amount of metallosis on the left l3 level and loosing of the set screw.

 
Manufacturer Narrative

Product analysis: the set screw has a channel running through the equator of the set screw face. One side of the channel is thicker than that the other. There is a witness mark on the outer edge of the set screw. These two observations are consistent with the rod being over angulated in the bone screw head at the time of the set screw being installed. This could cause the rod not to set properly in the bone screw head. The root cause of the one set screw backing out is consistent with angle of the rod in respect to the saddle of the bone screw. This allowed the rod to move inside the bone screw head, removing material from the set screw. If information is provided in the future, a supplemental report will be issued.

 
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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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key7618081
MDR Text Key111615915
Report Number1030489-2018-00865
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK143375
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6440530
Device LOT Number0513384W
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/04/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/01/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/19/2016
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: 06/20/2018 Patient Sequence Number: 1
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