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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 8115545
Medical Device Problem Code Device Slipped (1584)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/23/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Visual and microscopic inspection confirmed the set screws of the crosslink have been stripped.The female hex edges have been deformed and roll over.Unable to tighten and loosen center nut.It appears to be cross threaded.This type of damage is consistent with torsional overload.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient underwent lumbar posterior fusion technique due to lumbar degenerative.Intra-op, the product was slippery.No patient complications were reported for this 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 Key9731425
Report Number1030489-2020-00180
Device Sequence Number355923
Product Code KWP
UDI-Device Identifier00721902729713
UDI-Public00721902729713
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K030840
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) 02/20/2020
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 Number8115545
Device Lot Number0706226W
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/27/2020
Initial Report FDA Received Date02/20/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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