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

Catalog Number	8690024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2017
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.Product image review: submitted image appears to display implant rod fracture.X-ray review: post-op x-rays and camera images of broken rod from long segment thoracic-lumbar fusion show a unilateral fractured rod.No lateral imaging is provided to demonstrate the sagittal deformity.Hardware placement appears appropriate."pre stress" of the rod and fracture of fusion at the deformity apex may contribute to rod fracture.
Event or Problem Description
It was reported that the patient underwent posterior instrumentation at t8-l5.Post-op, the rod breakage was observed on (b)(6) very close to l4-5 and s1.Hence, a revision surgery was performed to explant the broken rod and then double titanium rod was implanted.
Additional Manufacturer Narrative
Product analysis- visual review confirmed rod breakage.Optical examination of the fracture surface found damage and smearing.The fractures were fairly flat with only a slight shear lip.This type of fracture is more consistent with cyclic fatigue than a sudden overload.No additional information can be obtained to the on fracture surfaces due to as received condition.Dimensional inspection of rod diameter in several areas confirmed 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 implant or associated components.It was unable to definitively determine a specific root cause of the foregoing event from the available information.X-ray review: multiple x-ray images for t8-l6 were provided.Rod fracture was identified at l2-3 level.Fracture at 5 years post surgery and 1.5 years, post revision by report likely caused is failure of bony fusion at mobile lumbar segment.Over contouring of rod is also mentioned in report.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: 6979051
• Report Number: 1030489-2017-02260
• Device Sequence Number: 19004086
• Product Code: KWP
• UDI-Device Identifier: 00613994161598
• UDI-Public: 00613994161598
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K043488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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: 8690024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 02/15/2018
• 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: Required Intervention
• Patient Weight: 64