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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 Problem Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2018
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

Pre-operative diagnosis- disc decompression procedure- internalfixation it was reported that intra-op, set screw slipped during tightening. No patient complications were reported. The product came in contact with the patient.

 
Manufacturer Narrative

Product analysis: analysis revealed thread crest/flank damage; this damage appears to have initiated near the start of the thread and is evident around the damaged portion of the thread. Functional evaluation with a sample mas head found the set screw was unable to be fully engaged. 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 Key8198841
MDR Text Key131480558
Report Number1030489-2018-01705
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeCH
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 03/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6440530
Device LOT Number0655774W
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/17/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/18/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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