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

Model Number 1556300500

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k number: the device p/n 1556300500 is similar to the device manufactured in us p/n 1556000500.Hence, mentioned 510k licence number k111942 is of p/n 1556000500.Evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding an unknown patient with a l5/s bone union failure indication for spinal fusion therapy.It was reported that the implanted rod on (b)(6) 2016 which broken off at l5/s and bone union failed.There was a revision surgery performed to replace and reinforcement of rod with mrc (multi rod constructs) were performed.There was no report of injury to the patient as a result of this event.There was an additional surgery performed as a result of this event.There was no delay in overall procedure time.There was no need in-patient hospitalization or prolongation of existing hospitalization necessary as result of this event.No health damage in the patient was reported.Additional information was received on 2020-aug-07: tlif (using cage by another company) was performed at l5/s in addition and it was performed additionally to the bone that had become a mass((from)the level above is unknown.-(to) l5), so there may have been an effect of bone union on l5/s.There were no symptoms had seen prior and post to revision surgery.

Manufacturer Narrative

H3: product analysis #(b)(4):(b)(6), lot# 0451855w, visual review confirms rod breakage.Visual and optical examination of the area of fracture initiation did not identify a pre-existing surface defect near the area of crack origination that could contribute to crack propagation.Significant deformation at multiple locations along the length of rods due to apparent rod bending.Microscopic examination of the fracture surface identified a fairly flat fracture surface with shear lips towards the end of the break indicating material overload.The above observations are consistent with bend stress overload.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 10470016
• MDR Text Key: 205467228
• Report Number: 1030489-2020-01176
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2024
• Device Model Number: 1556300500
• Device Catalogue Number: 1556300500
• Device Lot Number: 0451855W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 58