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

Catalog Number	8690024
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: patient.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 via a patient call that on (b)(6) 2011, patient underwent an unspecified surgery using cobalt rods.In (b)(6) 2017, the patient was getting out of bed and had excruciating pain shoot up her back.She continued to stay in pain.She went to the doctor on (b)(6) 2018 and the an x-ray exam was done.One of the rods was found broken in her back.In (b)(6) the 2nd rod was also found to have broken and protruded through her back.On (b)(6) 2018, the surgeon went back in and did a 2nd surgery.Patient stays in pain and had 2 surgeries as a result of the rod breakage.No other info was available.

• 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: 7863634
• Report Number: 1030489-2018-01239
• Device Sequence Number: 11221444
• Product Code: KWP
• UDI-Device Identifier: 00613994161598
• UDI-Public: 00613994161598
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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: 8690024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 09/11/2018
• 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