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

Catalog Number	1555501070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that post-operatively patient had back pain and leg pain due to broken rods.The device came in contact with the patient.No fragments of broken rods were remained in patient.No patient complications occurred due to this event.
Additional Manufacturer Narrative
Additional information: product analysis: visual review confirms rod breakage.Damage and smearing noted on fracture surfaces.No pre-existing surface defects were identified that could contribute to the breaks.Dimensional inspection confirms conformance to print specification.After visual, microscopic and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implants.The above observations are consistent with material overload resulting from failure due to cyclic fatigue.If information is provided in the future, a supplemental report will be issued.

• 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: 7815801
• Report Number: 1030489-2018-01164
• Device Sequence Number: 2336459
• Product Code: NKB
• UDI-Device Identifier: 00643169081284
• UDI-Public: 00643169081284
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1555501070
• Device Lot Number: 0205411W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR