MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	75445530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.X-ray review: post op ct and ct reconstruction for l4-5 mid-lf show separation of one of the tulip head from the screw shank.Fusion status is unknown on the one provided axial ct since the screw does not have bicortical purchase.Failure of the head is likely a failure of fusion initially, although by report, fusion was eventually achieved.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that that on the patient underwent mini invasive listhesis at l4-l5 due to spondylolisthesis.Post-op, the tulip part of the screw broke inside the patient's body.No patient complications were reported as a result of the event.No additional surgery has been performed as a result of the event.The patient achieved solid fusion.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7422378
• Report Number: 1030489-2018-00541
• Device Sequence Number: 37688
• Product Code: KWP
• UDI-Device Identifier: 00885074133997
• UDI-Public: 00885074133997
• Combination Product (Y/N): N
• Initial Reporter Country: MD
• PMA/510(K) Number: K042025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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: 75445530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 70