MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M

Model Number 6550017

Device Problem Device Handling Problem (3265)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Radiographic image review : lateral x ray l4-5 fusion, one of the l5 extender tab is present on the screw tulip.H6 - the device was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 healthcare provider (hcp) via a manufacturer representative regarding a patient who had tlif l4-5.It was reported that surgeon placed 4 voyager screws in l4-5.Confirmed placement via o arm spin.He then proceeded to drop 2x 30mm capped rod and final tighten with 4 set screws.The extender caps were removed and the break off instrument was used on patients.A final ap or lateral image was not done before closing the surgeon doesn't request one.Additionally the tabs that were broken off with the break off tool but the break off portion of the screws were not counted as the facility does not require them to be counted.The extenders with tabs remaining from use (4) were thrown into a tray and sent down to spd.Post op imaging days after the case identified that a tab from the l5 left screw did not break off and was remaining inside the patient affixed to the screw.On 22 nov 2023, removal of this tab was complete.No identified damage to the screw or the break off portion was noticed.There was no patient involvement/symptom reported.There were no further complications reported regarding the event.

Manufacturer Narrative

A4: patient weight updated.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 healthcare provider (hcp) via a manufacturer representative regarding a patient who had tlif l4-5.It was reported that surgeon placed 4 voyager screws in l4-5.Confirmed placement via o arm spin.He then proceeded to drop 2x 30mm capped rod and final tighten with 4 set screws.The extender caps were removed and the break off instrument was used on patients.A final ap or lateral image was not done before closing the surgeon doesn't request one.Additionally the tabs that were broken off with the break off tool but the break off portion of the screws were not counted as the facility does not require them to be counted.The extenders with tabs remaining from use (4) were thrown into a tray and sent down to spd.Post op imaging days after the case identified that a tab from the l5 left screw did not break off and was remaining inside the patient affixed to the screw.On 22 nov 2023, removal of this tab was complete.No identified damage to the screw or the break off portion was noticed.There was no patient symptom reported.There were no further complications reported regarding the event.

Manufacturer Narrative

B5: patient involvement / complications has been corrected h6: patient code (ime) was corrected 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® VOYAGER¿ SPINAL SYSTEM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED M
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 18336215
• MDR Text Key: 330610515
• Report Number: 1030489-2023-00849
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00643169754584
• UDI-Public: 00643169754584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6550017
• Device Catalogue Number: 6550017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 78 KG