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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 8115528
Medical Device Problem Code Device Damaged by Another Device (2915)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/08/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product is not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.
 
Event or Problem Description
It was reported that patient with osteomyelitis underwent lumbar fusion.Intra-op, the torque limiting mechanism failed to operate properly causing the screw to strip.There were no fragments remaining inside the patient.No patient complications were reported.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key6607240
Report Number1030489-2017-01434
Device Sequence Number11743
Product Code KWP
UDI-Device Identifier00721902729522
UDI-Public00721902729522
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
K030840
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 05/09/2017
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 Number8115528
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 05/09/2017
Supplement Date Received by Manufacturer05/09/2017
Initial Report FDA Received Date06/02/2017
Supplement Report FDA Received Date10/04/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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