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 r eported event.
Event or Problem Description
It was reported that an unknown date patient underwent spinal fusion surgery at sacral- iliac.Post-operatively, it was reported that screw seemed to be loosening from their set screw.The set screw is no longer locked in the screw tulip, allowing the rod to be free moving.As a result, pain was observed in the patient.
Additional Manufacturer Narrative
X-ray review: post-op x-rays were provided for t10-iliac fusion.Dates on films are not provided.On one of the images, it appears that the rods are not seated in the iliac screw heads.No details are provided about the location of hardware failure otherwise.The degree of deformity correction is difficult to assess without standing films but there appears to be a sagittal imbalance and kyphosis above the construct on one of the provided images additionally.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: 7153737
• Report Number: 1030489-2017-02585
• Device Sequence Number: 13814845
• 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): 01/23/2018

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: 12/29/2017
• Supplement Report FDA Received Date: 01/23/2018
• 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: Other