MAUDE Adverse Event Report: WARSAW ORTHOPEDICS CD HORIZON SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 1556300500

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

This device is not approved for sale in us but a similar device with catalog # 1553201035, 510k# k113174 and upn (b)(4) is approved for sale in us.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.X-ray review: post-op x-rays for t8-sacrum fusion show a persistent deformity in the sagittal and coronal planes.There is a bilateral rod fracture at the inferior aspect of the construct.Fusion status is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Pre-operative diagnosis of initial surgery: degenerative lumbar kyphoscoliosis (t9/s2) procedure used in the initial surgery: thoracolumbar vertebra posterior fusion pre-operative diagnosis for revision: reinforcement was performed with 4 rods due to rod breakage (t9/s2) it was reported that the patient underwent a fusion surgery due to degenerative lumbar kyphoscoliosis using rods.Post-op, the rods at both sides of l3/l4 level broke.Additional surgery was performed as a result of the event.The rod of the caudal side was removed and replaced by a new rod.Part of the broken rod was left as it was, and reinforcement was performed with 4 rods.No patient complications were reported as a result of the event.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8177674
• MDR Text Key: 130770291
• Report Number: 1030489-2018-01668
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1556300500
• Device Lot Number: 0441705W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR