MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SOLERA VOYAGER SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 55750047535

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problem Unspecified Nervous System Problem (4426)

Event Date 10/17/2022

Event Type  Injury  

Event Description

It was reported that after the procedure the screws were deviated.There is a possibility of l5 root symptoms after surgery and prolonged hospitalization to fix again through revision surgery.No further complications or symptoms were reported.Additional information has been received via manufacturer representative that all the reported screws were deviated after initial surgery and were explanted in the revision surgery.The lot numbers of the reported products are unknown.Additional information has been received via manufacturer representative that as a result of the verification, it became clear that it was a human error.In a lateral decubitus position, a cage was inserted using the olif at this hospital, and then the percutaneous pedicle screw (pps) was performed as is in a lateral decubitus position.Upon navigation after the cage insertion, the vertebral body moves due to the cage, so the o-arm imaging was performed again navigation was used; accidentally selected the o-arm imaging data before inserting the cage on the navigation even during pps, and the screw was inserted unnoticed as is.Therefore, it was decided that even though the screw insertion was accurate on the navigation system, it was actually deviating.Re-operation was completed successfully.

Manufacturer Narrative

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.

Manufacturer Narrative

B5 and h6 are 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

Additional information has been received via manufacturer representative that the 3 dislodged screws were re-implanted in the revision surgery.The products will not be returned as they are implanted.

• Brand Name: CD HORIZON SOLERA VOYAGER SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 15786854
• MDR Text Key: 303548650
• Report Number: 1030489-2022-01033
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169749085
• UDI-Public: 00643169749085
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170679
• 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: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55750047535
• Device Catalogue Number: 55750047535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• 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