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

Model Number 1664017

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog # 6430530, 510k # k143375, udi# (b)(4).Was cleared in the united states.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.

Event Description

Information was received from a healthcare professional via manufacturer representative regarding a set screw used in for l4/5 pyogenic spondylitis it was reported that a rubbing sound of the implant was heard when the patient woke up during the outpatient care visit in (b)(6) 2022, when an x-ray was taken and the two set screws on the right side of the head were removed.There was a complaint that the rod was protruding and hurting.Additional surgery - nail removal at l1to il was performed.Since the crp has also been rising and it is unknown whether there are any effects on the surrounding tissue due to the abrasion of the implant, a culture test would be carried out on the ones that include wear debris, just in case.The patient was given an implant, so it could not be removed.Only an image was taken of the dislodgement part of the set screw.Theset screws for ll1 to il fixation and 1 and 2 on the right side were completely removed in that state.In addition to that, the set screw was also loose.Metal wear debris was confirmed in the l1, 2 screw head region.Heat generation was present at crp 13.There is no loosening of the pedicle screw.The device will not be returned as it is said that the patient will be given an implant on june 4, 2021, anterior l4/5 iliac bone graft and posterior pps (l1-il) fixation were performed due to l4/5 pyogenic spondylitis.It was a case where bone fusion had already been completed and the nail was under investigation.No patient symptoms were reported.No further complications were reported/anticipated.

• Brand Name: CD HORIZON® SOLERA® SPINAL SYSTEM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer (Section G): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 16066090
• MDR Text Key: 307294447
• Report Number: 1030489-2022-01140
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10.
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1664017
• Device Catalogue Number: 1664017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention