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

Catalog Number	8115558
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual and functional inspection confirmed that one of the break-off set screws of the crosslink has been broken.The cone shaped lower end of the screw has been completely broken off with about two thread rows still attached to it.The threads also show signs of bending/twisting before being detached from the rest of the screw.The top half of the screw shows signs of use and the last thread where the screw broke is severely damaged.It appears the screw was over-torqued causing the screw to break.The actual crosslink shows some minor surface scratches and the other set screw was not returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient was diagnosed with lumbar degeneration; and underwent lumbar internal fixation.Intra-op, the crosslink plate broke.The broken plate was completely explanted from the patient.No fragments of the broken implant remained inside the patient.No patient complications were reported.

• 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: 8076977
• Report Number: 1030489-2018-01492
• Device Sequence Number: 19422388
• Product Code: KWP
• UDI-Device Identifier: 00721902729782
• UDI-Public: 00721902729782
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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: 8115558
• Device Lot Number: 0288248W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1