MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	G7540020
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: other relevant device(s) are: product id: g7540220, serial/lot #: (b)(4), ubd: 03-nov-2019, udi#: (b)(4); product id: g7540220, serial/lot #: (b)(4), ubd: 11-dec-2020, udi#: (b)(4); product id: g7540220, serial/lot #: (b)(4), ubd: 07-nov-2019, udi#: (b)(4); product id: g7540220, serial/lot #: (b)(4), ubd: 03-nov-2020, udi#: (b)(4); product id: g7540220, serial/lot #: (b)(4), ubd: 07-nov-2019, udi#: (b)(4); product id: g75444525, serial/lot #: (b)(4), ubd: 24-jun-2016, udi#: (b)(4); product id: g75494530, serial/lot #: (b)(4), ubd: 24-mar-2017, udi#: (b)(4); product id: g75494535, serial/lot #: (b)(4), ubd: 20-mar-2017, udi#: (b)(4); product id: g75495535, serial/lot #: (b)(4), ubd: 30-oct-2019, udi#: (b)(4); product id: g75495540, serial/lot #: (b)(4), ubd: 07-apr-2017, udi#: (b)(4); product id: g75496535, serial/lot #: (b)(4), ubd: 02-nov-2017, udi#: (b)(4); product id: g75496535, serial/lot #: (b)(4), ubd: 03-nov-2017, udi#: (b)(4); product id: g75496540, serial/lot #: (b)(4), ubd: 16-feb-2021, udi#: (b)(4); product id: g7640220, serial/lot #: (b)(4), ubd: 03-sep-2017, product id: g7640220, serial/lot #: (b)(4), ubd: 09-dec-2019, udi#: (b)(4); product id: g7640220, serial/lot #: (b)(4), ubd: 08-jan-2020, udi#: (b)(4); product id: g76494525, serial/lot #: (b)(4), ubd: 12-sep-2021, udi#: (b)(4); product id: g76494525, serial/lot #: (b)(4), ubd: 23-oct-2020, udi#: (b)(4); product id: g76494530, serial/lot #: (b)(4), ubd: 21-sep-2017, udi#: (b)(4); product id: g76494530, serial/lot #: (b)(4), ubd: 15-dec-2019, product id: g76495540, serial/lot #: (b)(4), ubd: 13-dec-2019, udi#: (b)(4); product id: g76496535, serial/lot #: (b)(4), ubd: 04-jun-2017, udi#: (b)(4); product id: g76496535, serial/lot #: (b)(4), ubd: 10-sep-2020, udi#: (b)(4); product id: g76496540, serial/lot #: (b)(4), ubd: 05-jun-2017, udi#: (b)(4); product id: g828h083, serial/lot #: (b)(4), ubd: 02-jun-2018, udi#: (b)(4); product id: g869h021, serial/lot #: (b)(4), ubd: 17-jun-2018, udi#: (b)(4); product id: g811h404, serial/lot #: (b)(4), ubd: 03-feb-2019, udi#: (b)(4); product id: g811h408, serial/lot #: (b)(4), ubd: 09-oct-2021, udi#: (b)(4); product id: g75495530, serial/lot #: (b)(4), ubd: 09-nov-2020, udi#: (b)(4); product id: g76494530, serial/lot #: (b)(4), ubd: 17-oct-2019, udi#: (b)(4); product id: g76494530, serial/lot #: (b)(4), ubd: 12-jan-2020, udi#: (b)(4).Foreign.Country: (b)(6).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.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 plif.It was reported that the patient presented postoperative metal allergy and the additional surgery was performed for the removal of device on (b)(6) 2022. the initial operation was performed at iwate medical university hospital on (b)(6) 2014. there was no allegation about faulty products, but the patient experienced metal allergy symptoms that are considered due to implanted products. there were no further complications reported regarding the event.
Additional Manufacturer Narrative
H6.Fdd code corrected.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 SPINAL SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14600355
• Report Number: 1030489-2022-00520
• Device Sequence Number: 5164654
• Product Code: KWP
• UDI-Device Identifier: 00613994143181
• UDI-Public: 00613994143181
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• 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): 02/08/2024

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: 07/22/2021
• Device Model Number: G7540020
• Device Catalogue Number: G7540020
• Device Lot Number: H13E4011
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 02/08/2024
• Date Device Manufactured: 07/22/2013
• 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: 33 YR
• Patient Sex: Female