MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number 5530030

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pain (1994)

Event Date 03/30/2022

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Information was received from a healthcare provider (hcp) via a medtronic representative regarding a patient previously implanted with spinal products in a thoracolumbar posterior fixation for a fracture at s2ais.It was reported that the second set screw was dislodged. no failures were reported for the other set screws and rods other than the 2nd backed out set screw.The patient complained of lower back pain as a result of this event. the patient needed to be hospitalized for re-surgery. the screw was replaced with a new one during the re-fixation surgery.The rod was removed to replace the screw in the revision surgery.The screw was replaced and fixed with a new rod and new set screw because the screw head may have been damaged.The products were fixed normally and no abnormalities were reported.The dates of implant was (b)(6) 2022 and date of refixation was (b)(6) 2022.No further complications were reported/ anticipated.

Manufacturer Narrative

H3: product analysis part# 5530030 ; lot# h5697197- visual and optical inspection revealed some slight surface wear to the threads but no damage to the female torx of the set screw.Functional check with a sample bone screw confirmed the set screw was able to thread into the head of the screw without any issue.No signs of off axis/ uneven wear on the bottom surface from the seating of the rod.The screw appears to function as intended and there was no fault found.H6: updated eval.Code method, eval.Code result, and eval.Code conclusion post analysis.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): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14301828
• MDR Text Key: 291323759
• Report Number: 1030489-2022-00438
• Device Sequence Number: 1
• Product Code: KWP
• UDI-Device Identifier: 00643169210158
• UDI-Public: 00643169210158
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K202328
• 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,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5530030
• Device Catalogue Number: 5530030
• Device Lot Number: H5697197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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; Hospitalization
• Patient Sex: Male