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

Catalog Number	869-011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
It was reported that the patient underwent pedicle subtraction osteotomy(pso) at l3 for correction of sagittal balance.Post-op, the implanted rods broke due to patient's fall on back by being pushed.As a result, a revision surgery was performed to completely explant the broken rods, to stabilize patient's condition.No patient complications were reported.
Additional Manufacturer Narrative
X-ray review- post-op x-rays for thoracolumbar fusion showed bilateral rod fracture after more than 1 year from the surgery.Lateral bony fusion appeared present at the lumbar levels below the fracture on one of the provided ap(anterior posterior) images although this would be better assessed by ct.This fracture was presumably caused due to patient's trauma.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
In the revision surgery, stabilization was performed from t7-l5; a combination of remaining ti rod with double cocr rod and mrc connector was used to secure solid construction for optimal fusion.

• 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: 7174343
• Report Number: 1030489-2018-00028
• Device Sequence Number: 11072089
• Product Code: KWP
• UDI-Device Identifier: 00721902750991
• UDI-Public: 00721902750991
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K031655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 869-011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 01/24/2018
• 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: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 100