MAUDE Adverse Event Report: MDT Puerto Rico Operations Co, Med Rel VERTEX® Reconstruction System; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	6958814
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from multiple sources (healthcare professional, distributor) regarding a screw used for pedicle screw fixation surgery with transforaminal lumbar interbody fusion therapy.It was reported that, prior to a pedicle screw fixation surgery with transforaminal lumbar interbody fusion, a medtronic mas screw was identified as having a screw head defect in which the distance between the two wings of the screw head was narrower than normal.It was reported that the inner set screw could not be inserted properly and the rod could not be securely locked in place. there was no patient involvement reported.There were no further complications reported regarding the event.
Additional Manufacturer Narrative
H3: product analysis # (b)(4): part # 6958814, lot # h5910693 visual inspection confirmed the head of the screw has been bent.Optical inspection revealed surface scratches on both sides of the pedicle head indicating the screw head has been overloaded.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: VERTEX® Reconstruction System
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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 ; +1(763)526-5677
• MDR Report Key: 50878875
• Report Number: 2647346-2026-00533
• Device Sequence Number: 16124894
• Product Code: KWP
• UDI-Device Identifier: 00613994354808
• UDI-Public: (01)00613994354808(11)240112(10)H5910693
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K081297
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 6958814
• Device Catalogue Number: 6958814
• Device Lot Number: H5910693
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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: 42 YR
• Patient Sex: Male