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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Catalog Number 8116458
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/27/2017
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that the patient underwent internal fixation due to lumbar spondylolisthesis.During the spinal surgery, the screw was damaged after the implant placement.The product was completely explanted from the patient.No patient complications were reported as a result of the event.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
Common Device Name
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key7319582
Report Number1030489-2018-00314
Device Sequence Number10790566
Product Code KWP
UDI-Device Identifier00721902819681
UDI-Public00721902819681
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K031888
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number8116458
Device Lot Number0563317W
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/07/2018
Initial Report FDA Received Date03/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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