MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM

Catalog Number	779115555
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 connectors broke preventing from fusion.As the result, patient suffered with 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 of the connector confirmed deformation of the rim of the rod entry point and various witness marks.The uneven witness marks inside the rod connector indicate the rod was not seated flush and parallel against the break off screw.The set screw appear to have backed out causing the rods to slip and flex causing the damage to the rod connector.This is consistent with the screw backing out overtime.: 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
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 8144596
• Report Number: 1030489-2018-01618
• Device Sequence Number: 11189035
• Product Code: NKB
• UDI-Device Identifier: 00613994739353
• UDI-Public: 00613994739353
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101074
• 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: 779115555
• Device Lot Number: 0586692W
• 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