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	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 the patient underwent unspecified surgery.Post-op, the patient complained of pain and it was confirmed through radiography that the rod parts have been broken and thus a revision surgery was performed to replace the rod.The patient was in a good condition after the revision.
Additional Manufacturer Narrative
Image review: post-op x-rays at an undetermined time from initial implant show long segment hole and rod construct for thoraco lumbar fusion.There is a fracture of the rod at the transition, probably as a result of failure of fusion.There is straightening of the thoracic lordosis.It is not possible to judge sagittal balance on the provided image.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: 7771786
• Report Number: 1030489-2018-01119
• Device Sequence Number: 11015882
• Product Code: KWP
• UDI-Device Identifier: 00721902750991
• UDI-Public: 00721902750991
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• PMA/510(K) Number: K031655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2018

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
• Device Lot Number: 0399077W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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; Required Intervention
• Patient Age: 54 YR