MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO, MED REL VERTE-STACK® SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	9193014
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having tlif-transforam inal lumbar interbody fusion spinal therapy for lumbar degeneration requiring 2 level tlif procedure.Levels implanted at l4/5 and l5/s1.It was reported that as the surgeon was starting to place the cage insitu in the disc space he started to impact the inserter and suddenly the cage cracked/breakage.The cage looked to have been attached properly to the inserter by the scrub nurse and also wasn¿t being forced into the disc space with undue force.  there was no patient symptom reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
G2: country of origin is new zealand.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: product analysis #(b)(4): part # 9193014, lot # h5467897 visual and optical inspection revealed the implant is damaged.The implant has cracked near the top of the implant.The implant is fragile and can be overloaded.It appears the implants structural integrity was overloaded during the implantation procedure.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VERTE-STACK® SPINAL SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO, MED REL; road 909, km. 0.4., barrio mar; humacao PR 00792
• Manufacturer Contact: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; 7635265677
• MDR Report Key: 23581103
• Report Number: 2647346-2025-00216
• Device Sequence Number: 18552046
• Product Code: MQP
• UDI-Device Identifier: 00885074520742
• UDI-Public: (01)00885074520742(17)260914(10)H5467897
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K052261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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 Expiration Date: 09/14/2026
• Device Model Number: 9193014
• Device Catalogue Number: 9193014
• Device Lot Number: H5467897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2018
• 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 Sex: Unknown