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

Catalog Number	641100050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 that the patient was pre-operatively diagnosed with lumbar canal stenosis (lcs) and underwent posterior lumbar interbody fusion (plif) surgery at l5/s level.Post-operatively, the rod was broken.As a result, revision surgery was performed to replace the broken rod.It seemed that bone fusion had not been completed yet.No fragment of the alleged rod remained in the patient.Patient complications were unknown.
Additional Manufacturer Narrative
Product analysis results: visual optical microscopic dimensional visual review confirmed the rod has broken.Multiple witness marks noted on rod.Optical inspection did not reveal any surface defects to the area of initial crack propagation that could contribute to crack initiation and propagation.Significant fracture surface damage and smearing is noted.Microscopic examination of the undamaged portions of the fracture surface identified a fairly flat fracture, with initial gently convex progressive striations and beach marks through the cross-sectional area.Dimensional inspection confirms rod diameter to be within print specification.After visual, microscopic and dimensional inspection, no evidence was found that would suggest a defect in manufacturing or processing of the implants.The above observations are consistent with cyclic fatigue as the mechanism of failure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SOLERA 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: 8263480
• Report Number: 1030489-2019-00075
• Device Sequence Number: 1692629
• Product Code: NKB
• UDI-Device Identifier: 00643169501423
• UDI-Public: 00643169501423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143375
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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 Expiration Date: 09/04/2023
• Device Catalogue Number: 641100050
• Device Lot Number: 0414885W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 07/04/2019
• 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: Required Intervention