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

Catalog Number	1554006300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis result: observation: section of broken rod returned is approximately 28.5mm long.Microscopic review of the fracture face o there is smearing from post fracture damage on 50 percent of the fracture face.There are convex striations (beach marks) that emanate out of the area of crack propagation.These lines can be seen through 75 percent of the cross section and are noted up until the point of surface smearing.The witness mark from the bone screw head located 4.5mm from the fracture is heavier on one side, indicating the rod may not have been level and sitting flush in the head of the bone screw.Conclusion: the above observations are consistent with cyclic fatigue.The force applied to the area of fracture may have been increased due to the rod not being flush in the bone screw head.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent posterior spinal fusion due to spinal stenosis, degenerative disc disease.Post-op, it was found that the implanted rod had broken down at the s2 screws, from the bottom of the construct.The rod looked like it had pulled away from the cap screw.There were no patient symptoms or complications as a result of this event.Revision surgery has been performed to remove the broken rod.
Additional Manufacturer Narrative
X-ray image review result: post-op x-ray for anterior/posterior lumbar sacral fusion shows fracture of the one of the rods above the iliac screw.By report this happened in the early post-op period refers fusion would be expected to have occurred in this (b)(6) year old patient.Bone quality and degree of deformity correction are unknown.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: 8273325
• Report Number: 1030489-2019-00082
• Device Sequence Number: 13494760
• Product Code: KWP
• UDI-Device Identifier: 00643169217096
• UDI-Public: 00643169217096
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1554006300
• Device Lot Number: 0527844W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR