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

Catalog Number	1475501060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	11/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the patient had a revision extension fusion 1 level up.Post-op, rod broke.Patient experienced back pain and was referred to a neuro surgeon.After x rays, it was confirmed that a rod had broken and there was no bony fusion.Revision surgery was performed to explant the rod.
Additional Manufacturer Narrative
Product analysis:the rod was returned fractured ~30mm from the end.The fracture is fairly flat with only a small shear lip near the end.There is a good deal of damage/smearing to the fracture surface from the two ends of the rods rubbing together.There does not appear to be any defects in the material around the fracture level to indicate a manufacturing issue.The o.D of the rod is 4.78mm which is within the print specification.The attachments reveal that the rod had been implanted for 5 years this along with the physical evidence of the fracture indicated that wear may have contributed to the fail of the rod.If information is provided in the future, a supplemental report will be issued.

• 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: 7141658
• Report Number: 1030489-2017-02551
• Device Sequence Number: 1132596
• Product Code: KWP
• UDI-Device Identifier: 00613994792716
• UDI-Public: 00613994792716
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K113174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: 1475501060
• Device Lot Number: 8212788W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 12/22/2017
• Supplement Report FDA Received Date: 05/02/2018
• 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
• Patient Age: 50 YR