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

Model Number 5530230

Device Problem Material Deformation (2976)

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

Event Date 03/27/2021

Event Type  malfunction  

Manufacturer Narrative

This part is not approved for use in the united states; however a like device catalog #5540230, 510k# k113174 is marketed in the united states.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the healthcare professional (hcp) via the manufacturer representative regarding an event which occurred during a scoliosis fusion surgery in a patient diagnosed with adolescent idiopathic scoliosis.It was reported that the tip of the driver broke when the reduction set screw was fixed (during breakoff).Tip debris of the break off driver was found inside torx hole of the reduction set screw, and the tip of the set screw and threads were found to be damaged.There was a delay of less than 60 mins.No patient injury / complication was reported.

Manufacturer Narrative

H3: product analysis: part # 5530230, lot # 0814134w visual and macroscopic examination revealed thread crest/flank damage; this damage appears to have initiated at or near the start of the thread and is evident around the damaged portion of the thread.Functional evaluation with sample bone screw revealed the set screw was unable to be fully engaged.The above observations are consistent with misalignment of the bone screw and set screw threads during construct assembly.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: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 11676719
• MDR Text Key: 249661196
• Report Number: 1030489-2021-00498
• Device Sequence Number: 1
• Product Code: KWP
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5530230
• Device Catalogue Number: 5530230
• Device Lot Number: 0814134W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 51