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

Catalog Number	X0311334
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	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 on an unknown date patient underwent spinal fusion surgery at s2 trans-sacral.Post operatively, it was reported that the screw seemed to be loosening its set screw.Patient suffered with pain as a result of the event.
Additional Manufacturer Narrative
X-ray review: post op x-ray for thoraco ¿ ilium fusion provided.There appears to be loosening of the ilium set screws.On one side of the construct, the rod appears too short.This failure may be caused by lack of bony fusion, failure to torque tighten the screws, or improper rod contouring leading to a ¿pre stress¿ on the screw head.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 INTERVERTEBRAL BODY
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 7153727
• Report Number: 1030489-2017-02579
• Device Sequence Number: 19320657
• Product Code: KWQ
• UDI-Device Identifier: 00643169015104
• UDI-Public: 00643169015104
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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: X0311334
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/01/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SET SCREW
• Outcome Attributed to Adverse Event: Other