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 Codes	Failure of Implant (1924); Pain (1994)
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.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 t10 fracture-thoracic kyphosis and underwent arthrodesis at t3-s1.Post-op, the rod broke into the connector preventing fusion.As a result, patient suffered from pain.T3-sacrum arthrodesis, rod replacement, screw replacement and nut replacement were performed as a revision surgery.
Additional Manufacturer Narrative
Product analysis: visual and optical inspection confirmed the rod was cut.Optical examination of the fracture surface found a fairly flat fracture surface with a slight shear lip and rays emanating away from the area of crack propagation, which is consistent with the rod being sheared prior to implanting.Multiple witness marks across the surface of the rod consistent with the seating of the rod in the mas screw heads.Dimensional inspection of rod diameter in several areas 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 implant or associated components.No fault found.: radiographic image review: post-op x-rays for bony segment thoraco-pelvic fixation for kyphotic deformity shows displacement of rods from connectors bilaterally.The connection between the upper and lower segments of the instrumentation occurs at the apex of the kyphotic deformity.This is a natural place for hardware failure to happen if fusion has not occurred.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: 8144600
• Report Number: 1030489-2018-01620
• Device Sequence Number: 16550318
• Product Code: KWP
• UDI-Device Identifier: 00613994161598
• UDI-Public: 00613994161598
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/27/2019

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: 8690024
• Device Lot Number: 0588044W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/27/2019
• 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: Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 55