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

Catalog Number	5442130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: only the nose portion of the screw was returned for analysis.The witness marks on the nose and fractured surface are consistent with pressure from the rod while under torsion.This combined pressure both parallel and perpendicular to the axis of the screw caused the material to overload.The ring for the center nut was returned.This type of shearing can be seen when the center nut is over tightened and the ring contacts the body of the crosslink.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent fusion at t6-t11 due to tumor.Intra-op, the bottom of the set screw of the crosslink sheared off.A circular washer also came off the crosslink.The sheared off set screw was removed.The surgeon left the crosslink implanted in the patient because the surgeon felt that the crosslink was securely attached to the rod.There were no patient symptoms or complications as a result of this event.

• 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: 8411324
• Report Number: 1030489-2019-00262
• Device Sequence Number: 1785380
• Product Code: NKB
• UDI-Device Identifier: 00613994776464
• UDI-Public: 00613994776464
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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: 5442130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1