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

Catalog Number	1475501120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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 post-operatively, the implanted rod broke.The patient began to experience severe back pains and found it difficult to get out of bed.As a result, the patient underwent an x-ray which revealed that the implanted rod had broken.The patient does not intend to have another back surgery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that on (b)(4) 2017 that the patient underwent x-ray l spine 4 views.Findings: since the reference exam, there has been the appearance of a fracture involving the posterior fixation rod on the right at the level of the l4-l5 disc space.The proximal fracture end is situated medial to the distal fracture end at the l4-5 disc space.The surgical hardware is otherwise intact and unchanged compared to the previous study.Frontal view demonstrates mild height loss involving the left side of the l1 vertebral body which is a new finding compared to reference study.This results in a mild scoliosis of the lumbar spine convexity directed leftward.The scoliosis was worsened compared to reference study.Neutral lateral view demonstrates approximately 5 mm of retrolisthesis of l2 on l3 which is unchanged compared to reference study.This remains unchanged with flexion-extension.Lumbar contour and alignment is otherwise normal.Lumbar body heights are well maintained at every level.There is a marked disk space height loss at l1-l2 which has progressed slightly in the interval and is now satiated with adjacent endplate sclerosis.Study is otherwise unremarkable.

• 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: 7608941
• Report Number: 1030489-2018-00862
• Device Sequence Number: 13841633
• Product Code: KWP
• UDI-Device Identifier: 00613994792594
• UDI-Public: 00613994792594
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: 1475501120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/18/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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