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

Model Number 6440530

Device Problems Device Slipped (1584); Failure to Align (2522)

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

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare provider via field representative regarding patient with symptoms of lumbar disc herniation involved in posterior lumbar decompression and fusion therapy.It was reported during use, when the screw plug was installed, the set screw plug wire slipped, and it could not be screwed and had been taken out.The product was replaced.There were no patient symptoms or complications reported as a result of the event.Patient is alive and no injury.

Manufacturer Narrative

H3: device evaluation summary: visual and macroscopic inspection confirmed the threads of the break off screw have been damaged.The thread crest and flank damage appear to have initiated at the start of the thread and is consistent around the damaged portion of the thread.Functional evaluation with a sample mas found the set screw unable to be fully engaged in the mas head.The above observations are consistent with misalignment of the mas and set screw threads during construct assembly.Additional information: d8, d9, g3, h3, h6.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 SOLERA 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: 10513335
• MDR Text Key: 206345801
• Report Number: 1030489-2020-01252
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K143375
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6440530
• Device Catalogue Number: 6440530
• Device Lot Number: 0756941W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 11/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1