MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON FENESTRATED SCREW SET; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	55750026550
Medical Device Problem Codes	Break (1069); Malposition of Device (2616)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown which two screws from the reported products broke.Supplemental reports will be submitted for them upon receiving additional information.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 55750026555, serial/lot #: (b)(6), ubd: 09-apr-2026, udi#: (b)(4); product id: 55750026555, serial/lot #: (b)(6), ubd: 09-apr-2026, udi#: (b)(4); product id: 55750026550, serial/lot #: (b)(6), ubd: 11-jul-2026, udi#: (b)(4); product id: 55750026540, serial/lot #: (b)(6), ubd: 22-nov-2026, udi#: (b)(4); product id: 55750026540, serial/lot #: (b)(6), ubd: 22-nov-2026, udi#: (b)(4); product id: 55750026555, serial/lot #: (b)(6), ubd: 09-apr-2026, udi#: (b)(4); product id: 55750026555, serial/lot #: (b)(6), ubd: 09-apr-2026, udi#: (b)(4).Radiographic image review: 1) ap x-ray post op multilevel l3-s1, posterior spinal fusion interbody grafts l3-4, l4-5, l5-s1.2) lateral view of 1), one of the s1 screws may be fractured.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 a spinal therapy.It was reported that both s1 screws (right and left) were broken.The products were explanted but the tips remained inside the patient.It was a revision case.The patient had pseudarthrosis and a screw was in the canal for this reason, the patient was operated. there was no patient symptom reported.There were no further complications reported regarding the event.
Event or Problem Description
Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.
Additional Manufacturer Narrative
H1: review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunction.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.Allegation has been confirmed against the screws product# 55750026540, lot# h5724764 (quantity:2) and regulatory rep# 1030489-2023-00679 and 1030489-2023-00680 have been submitted for the same.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 FENESTRATED SCREW SET
• 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: 17584208
• Report Number: 1030489-2023-00593
• Device Sequence Number: 14653142
• Product Code: NKB
• UDI-Device Identifier: 00763000148843
• UDI-Public: 00763000148843
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K201362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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 Expiration Date: 06/25/2026
• Device Model Number: 55750026550
• Device Catalogue Number: 55750026550
• Device Lot Number: H5676732
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 10/05/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 115 KG