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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM

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WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM Back to Search Results
Catalog Number 779115555
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Product was not 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 was pre-operatively diagnosed with t10 fracture-thoracic kyphosis and underwent arthrodesis at t3-s1. Post-op, the connectors broke preventing from fusion. As the result, patient suffered with pain. T3-sacrum arthrodesis, rod replacement, screw replacement and nut replacement were performed as a revision surgery.
 
Manufacturer Narrative
Product analysis: visual and optical inspection of the connector confirmed deformation of the rim of the rod entry point and various witness marks. The uneven witness marks inside the rod connector indicate the rod was not seated flush and parallel against the break off screw. The set screw appear to have backed out causing the rods to slip and flex causing the damage to the rod connector. This is consistent with the screw backing out overtime. Radiographic image review: post-op x-rays for bony segment thoraco-pelvic fixation for kyphotic deformity shows displacement of rods from connectors bilaterally. The connection between the upper and lower segments of the instrumentation occurs at the apex of the kyphotic deformity. This is a natural place for hardware failure to happen if fusion has not occurred. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameCD HORIZON SPINAL SYSTEM
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 Key8144597
MDR Text Key129747562
Report Number1030489-2018-01617
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K101074
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 02/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number779115555
Device Lot Number0586692W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2017
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: 12/07/2018 Patient Sequence Number: 1
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