MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	1555000500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Image review:post op x-ray for t10-l5 posterior spinal fixation shows rod fracture at l3-4.This occurred during patient motion and is likely the result of failure of fusion at this lower lumbar level.Hardware placement otherwise appears appropriate.Product was not 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 was pre-operatively diagnosed with scoliosis and back pain and underwent scoliosis correction from t10 to l5 and laminectomy t12-l4.Post-op, rod breakage was observed after patient's lateral bending movement.Pain was observed as the result of the event.Broken rod replacement was performed due to the event.No fragments of the broken part remained in the patient.
Additional Manufacturer Narrative
Additional info: visual review confirms rod breakage.Optical and dimensional examination showed damage and smearing noted on fracture surfaces.No pre-existing surface defects were identified that could contribute to the breaks.Dimensional inspection confirms conformance to print specification.After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implants.The above observations are consistent with failure due to cyclic fatigue.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 7438223
• Report Number: 1030489-2018-00568
• Device Sequence Number: 1513546
• Product Code: KWP
• UDI-Device Identifier: 00613994990037
• UDI-Public: 00613994990037
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1555000500
• Device Lot Number: 0319130W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2018
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 04/17/2018
• Supplement Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 74