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

Model Number	55850016540
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2002
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Type of reportable event: modified surgical procedure (surgeon convert the surgery to open).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 or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having percutaneous sp ine surgery for unknown indication.It was reported that on (b)(6) 2022, at the cafam 93 clinic, 1-level percutaneous spine surgery was started on the patient (b)(6), two 10-mm pak-type guides were passed to take the pedicles where taking them is difficult.Since they were not well visualized, the nitinol guides are passed to be able to place the screws, dr.(b)(6) tells me that the screws to be placed must be 6.5x 40mm ref (b)(4), once all the screws have been placed, proceed to measure the bar, it is cut, folded and placed in the screws, it is verified that the bar is inside the head of the screws, the first stop ref (b)(4) is placed, which enters normally when placing the second stop, it enters with difficulty is verified by x-rays the position of the bar, this is positioned making the stop enters, the first stop is fractured, this fractures normally when fracturing the second, it does not fracture and the stop is trans-threaded, it is changed stop and this is also cross-threaded and does not allow it to fracture, the surgeon is suggested to use the reducers to lower the bar to the head of the screw, the stop is placed and this is also cross-threaded.Dr. (b)(6) decides to place the bar in the other screws, the first stop that enters normally is placed, the second is placed and this also enters normally, the first stop is fractured and this fracture at the time of fracturing the second the s top, like the top of the other screws, is trans-threaded, dr.(b)(6) removes the bar, places the screws, places the bar again, i have tried to fracture the second stop again, this one still does not fracture. after several attempts and trying with different stops, dr.(b)(6) decides to convert the surgery to open, a screw is repositioned, the bar is placed again and the stops are placed, where again the stop enters transthreaded and does not allow its fracture, it is suggested changing the screws, but the surgeon tries to place the rod in a new and loose screw from another reference in the rack, he places the rod and the stop where it is verified that it is transthreaded. the specialist decides to withdraw the system since in no way could these stops be fractured.Additional information received from manufacturer representative that the procedure involved was anterior cervical spine surgery.The products did not implant in the patient.There was a delay in over all procedure time.Products of other brand used to complete the surgery.
Event or Problem Description
Additional information received from manufacturer representative that the product will not be returned.
Additional 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.

• Brand Name: CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM
• Common Device Name: 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: 16156306
• Report Number: 1030489-2023-00033
• Device Sequence Number: 7563260
• Product Code: NKB
• UDI-Device Identifier: 00643169768260
• UDI-Public: 00643169768260
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K170679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 55850016540
• Device Catalogue Number: 55850016540
• Device Lot Number: H5688657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 04/24/2023
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female