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

Catalog Number	1606000500
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/21/2017
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
Patient clinical id: lucus 1-2-3-4 pre-op diagnosis: disbalance sagital lumbar procedure: scoliosis disbalance sagital level: t3-illiac it was reported that patient underwent a surgery.Post-op, pain and instability was observed in the patient.
Additional Manufacturer Narrative
(b)(4).X-ray review: post-op x-rays for long segment thoraco sacral fixation show a bilateral rod fracture and loss of saggittal balance.Fusion structures reported as solid, but imaging suggests otherwise.The second images provided still demonstrate a rod fracture in a different location, presumably after revision though the saggittal balance is better the second time.Root cause: undeterminate.
Event or Problem Description
It was reported post-op x-rays of long segment thoraco-sacral fixation that a bilateral rod fracture and loss of saggittal balance was observed.Fusion structures were reported as not so solid and revision surgery was scheduled.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6713265
• Report Number: 1030489-2017-01763
• Device Sequence Number: 16455483
• Product Code: NKB
• UDI-Device Identifier: 00613994974297
• UDI-Public: 00613994974297
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1606000500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/01/2017
• 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