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U.S. Department of Health and Human Services

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

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WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 1556300500
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
This device is not approved for sale in us but a similar device with catalog # 1553201035, 510k# k113174 and upn (b)(4) is approved for sale in us. Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. X-ray review: post-op x-rays for t8-sacrum fusion show a persistent deformity in the sagittal and coronal planes. There is a bilateral rod fracture at the inferior aspect of the construct. Fusion status is unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Pre-operative diagnosis of initial surgery: degenerative lumbar kyphoscoliosis (t9/s2) procedure used in the initial surgery: thoracolumbar vertebra posterior fusion pre-operative diagnosis for revision: reinforcement was performed with 4 rods due to rod breakage (t9/s2) it was reported that the patient underwent a fusion surgery due to degenerative lumbar kyphoscoliosis using rods. Post-op, the rods at both sides of l3/l4 level broke. Additional surgery was performed as a result of the event. The rod of the caudal side was removed and replaced by a new rod. Part of the broken rod was left as it was, and reinforcement was performed with 4 rods. No patient complications were reported as a result of the event.
 
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Brand NameCD HORIZON 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 Key8177674
MDR Text Key130770291
Report Number1030489-2018-01668
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1556300500
Device Lot Number0441705W
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/13/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/19/2018 Patient Sequence Number: 1
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