MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® BALLAST¿ SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	25840018580
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Post-op x-rays for iliac fixation showed fracture on one of the iliac screws.Levels are unknown.Fracture occurred 5-6 months post surgery.There is a paucity of graft in the l5-s1 interbody piece.The rest of the fusion status is unknown.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that, post-op, fracture of the screw was observed at si joint.No patient complications were reported as a result of this event at this time.

• Brand Name: CD HORIZON® BALLAST¿ SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 7300386
• Report Number: 1030489-2018-00284
• Device Sequence Number: 13692557
• Product Code: NKB
• UDI-Device Identifier: 00643169413269
• UDI-Public: 0643169413269
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2018

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: 25840018580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR