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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 1606000500
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/20/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.However, x-ray images were provided which were reviewed and the result is given below: image review: post op x-rays for long segment scoliosis construct shows a unilateral rod fracture.A single image is provided, deformity correction and fusion status can not be determined.
 
Event or Problem Description
Procedure: scoliosis adult levels: s1-iliac-t3 it was reported that on (b)(6) 2017, post-op, rod was found to be broken in x-ray image.Patient status was reported unknown.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
Common Device Name
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
WARSAW ORTHOPEDICS
2500 silveus crossing
warsaw IN 46582
MDR Report Key6727371
Report Number1030489-2017-01795
Device Sequence Number670446
Product Code NKB
UDI-Device Identifier00613994974297
UDI-Public00613994974297
Combination Product (Y/N)N
Initial Reporter CountrySP
PMA/510(K) Number
K131321
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/20/2017
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 Number1606000500
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/20/2017
Initial Report FDA Received Date07/20/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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