MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG VERTEX RECONSTRUCTION SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6958724
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a healthcare professional via manufacturer representative regarding screws and a rod used in cervical spine tumor resection and internal fixation therapy for cervical spine tumor.Levels implanted: c4-c7 it was reported that the two screws could not be locked after the set screws were installed.After the crosslink rod was kinked once, it could not be restored, so the operation was completed with a replacement of the same model of the medtronic product.Patient symptoms are unknown.No further complications were reported/anticipated.Additional information was received that the rod couldn't be folded back into the patient after being bent intra-operative.No patient symptoms were reported.
Additional Manufacturer Narrative
G2: country of origin is china.H3: product analysis of part# 6958724, lot# h5714985 visual and macroscopic inspection confirmed the threads of the screw have been damaged.The thread crest and flank damage appear to have initiated at the start of the thread and is consistent around the damaged portion of the thread.This is consistent with misalignment of the mas and set screw threads during construct assembly.H11: this regulatory report is being submitted due to retrospective review through capa 624392.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VERTEX RECONSTRUCTION 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 21035398
• Report Number: 1030489-2024-01849
• Device Sequence Number: 18425183
• Product Code: NKB
• UDI-Device Identifier: 00613994354990
• UDI-Public: 00613994354990
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 12/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6958724
• Device Catalogue Number: 6958724
• Device Lot Number: H5714985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2022
• Initial Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male