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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

Part is not approved for use in the united states; however a like device catalog # 1556200500, 510k# k131321 and udi # (b)(4) was cleared in the united states. 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: scoliosis type of procedure used: olif (oblique lumbar interbody fusion) of 3 inter-vertebral discs, posterior tlif (transforaminal lumbar interbody fusion) at single level, psf (posterior spinal fusion) levels implanted: t9-s2ai it was reported that on unknown date, post-op, the implanted rods broke. Revision surgery was scheduled for removal. No other info was available.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Post-op, due to the breakage of the rod, on (b)(6) 2017, the broken part was reinforced with connector from another manufacturer. Post the second surgery, the rod broke again. A revision surgery has been scheduled to be performed again.

 
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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 Key8202428
MDR Text Key131593991
Report Number1030489-2018-01710
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberSEE H10
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 01/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1556300500
Device LOT Number0405554W
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 Received12/13/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/26/2015
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: 12/28/2018 Patient Sequence Number: 1
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