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

Model Number 55850016550

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Information received from healthcare provider via manufacturer representative regarding an event happened during post op of the repo rted products.It was reported that, screw head with few threads length of the shaft has been explanted.The rest of the shaft has been left in the patient.The procedure involved was revision surgery to replace the screw, and initial procedure performed was mis l5/s1 instrumented fusion with right sided tlif.The levels implanted during initial surgery was left s1.It was unknown about the patient symptoms or complications as a result of this event.No further complications reported.

Manufacturer Narrative

Country of event - australia.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

H3: product analysis of part#55850016550 ; lot# h5650507 analysis summary: visual review confirms screw breakage approximately 3 threads down from the base of the bone screw neck.Visual and microscopic examination of the area of fracture initiation did not identify a pre-existing surface defect near the area of crack o rigination that could contribute to crack propagation.Significant fracture surface damage.Microscopic examination of the undamaged portions of the fracture surface identified a fairly flat fracture surface with some indication of multiple ratchet marks near the area of crack propagation, and gently convex progressive striations through the cross-sectional area of the bone screw.This type of damage is consistent with cyclic fatigue.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: 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: 15037700
• MDR Text Key: 296045252
• Report Number: 1030489-2022-00660
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00643169768284
• UDI-Public: 00643169768284
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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
• Device Operator: Health Professional
• Device Model Number: 55850016550
• Device Catalogue Number: 55850016550
• Device Lot Number: H5650507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 12/03/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 85 KG