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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ulcer (2274)
Event Type  Injury  
Manufacturer Narrative
Multiple devices were involved in the event. Since we cannot determine which of the devices led to the event, we are filing this report for notification purposes. Following devices are suspected to have contributed to the event: lot # 5432141, (b)(4), 5432147, (b)(4). 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. These parts are not approved for use in the united states; however, a like device catalog # 5442141, 510k # k091974 and upn# (b)(4) was cleared in the united states.
 
Event Description
Pre-op diagnosis: burst fracture at thoraco-lumbar junction part (fixation: 2a2b) procedure: posterior spinal fusion levels implanted: t10-l2 it was reported that on an unknown date, post-op, the part of the skin where the crosslink had been placed was damaged. The damaged site was at the stage prior to pressure ulcer. There was also pain due to protrusion of the device. Patient underwent a revision surgery for removal of all the implants.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6379662
MDR Text Key69094461
Report Number1030489-2017-00463
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
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 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/08/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/16/2013
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: 03/06/2017 Patient Sequence Number: 1
Treatment
SET SCREWS, SCREWS, RODS
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