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

Catalog Number	1475501070
Medical Device Problem Codes	Device Slipped (1584); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
X-ray results: post-of x ray for l4-5, fusion show that the rod is out of the l4 screw in one side.The rod appear short for the construct.Fusion status is unknown.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 underwent spinal fusion surgery at l4-s1 due to spondylolisthesis.Post-op, during a follow up x-ray it was determined that the rod had slipped out of the screw.Patient suffered with pain as a result of this event and underwent revision surgery.
Additional Manufacturer Narrative
Product analysis- visual inspection of the rod did not reveal any damages that could contribute to the rod slipping out from the saddle of the bone screw.Optical inspection confirmed normal surface scratches and witness marks from being implanted.Unable to determine root cause of the rod slippage.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: 8521854
• Report Number: 1030489-2019-00429
• Device Sequence Number: 19300494
• Product Code: KWP
• UDI-Device Identifier: 00613994792693
• UDI-Public: 00613994792693
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 1475501070
• Device Lot Number: 0577821W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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: 40 YR
• Patient Weight: 85