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

Catalog Number	1476000500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.H10: x-ray review findings: post-op x-rays for l4-s1 fusion are provided.A rod fracture is visible on one of the provided lateral x-rays.There are large metallic interbody grafts present, but there is a paucity of bone in both interbody spaces.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Pre-op diagnosis: instability type of procedure: fusion levels implanted: l4-s1 it was reported that on an unknown date, post-op, the rods on both sides broke after one year of fusion.The patient also experienced back pain.On (b)(6) 2018, a revision surgery was performed wherein the broken rods were explanted.The broken rods were replaced with rods from another manufacturer.No fragment of the broken rods remained in the patient.
Additional Manufacturer Narrative
Product analysis: visual review confirms rod breakage.Some fracture surface smearing noted.Optical and microscopic examination of the undamaged areas of the fracture surfaces identified a fairly flat fracture surface with gently convex progressive striations through the cross-sectional area of the rod, which are indicative of cyclic fatigue.Dimensional inspection rod diameter confirms conformance to print specification.No material damage noted on adjacent surface to crack propagation which could contribute to crack propagation.After visual, optical and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implant.The above observations are consistent with 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: 8291905
• Report Number: 1030489-2019-00098
• Device Sequence Number: 19133653
• Product Code: KWP
• UDI-Device Identifier: 00613994579522
• UDI-Public: 00613994579522
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 04/17/2019

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: 1476000500
• Device Lot Number: 0319331W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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: Required Intervention
• Patient Weight: 72