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

Model Number 5431195

Device Problem Break (1069)

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

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

Report source.Country: (b)(6).Device evaluation summary: damage was found on the threads.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via manufacturer representative regarding a patient with an indication of spinal canal stenosis in need of l1-s1 posterior spinal fixation used in spinal therapy.It was reported that after lamina hook on the right of l1 was placed, when tightening the rod, the rod could not be pushed down onto the screw well, after trying several times, the thread broke.After placing rod on the reported hook, when inserting set screw, the set screw could not be inserted well, a part of set screw separated in a beard-like shape.It was tried several times with a rod reducer, but the set screw could not be inserted as well.Therefore, a new hook was opened, bone cutting of the placement part was additionally performed to improve the fit for dealing with it.In appearance, the hook thread appeared to be damaged.The product came in contact with the patient.The set screws were presumed to be cross threaded due to procedure problem.All set screws were discarded.There was a delay of less than 60 mins in overall procedure time reported.There were no patient symptoms reported.There were no fragments in the patient reported.There were no further complications reported regarding the event.

Manufacturer Narrative

Device evaluation summary: visual and optical examination identified that the threads and the arm of the hook have been damaged.The damage of the threads appears to be from misalignment and the damage of the arm appears to be from contact of some other type of instrument.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: 10564911
• MDR Text Key: 207912190
• Report Number: 1030489-2020-01324
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K132111
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5431195
• Device Catalogue Number: 5431195
• Device Lot Number: 0667024W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1