MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. GENERIC INSTRUMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8361025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having l2-5 ps removal and replacement spinal therapy for adjacent segment disease after posterolateral fixation at l2-5, l5 intervertebral foraminal stenosis.Date of the initial surgery was (b)(6)2016.Procedure/therapy involved in the initial surgery was l2-5 posterolateral fixation and the reason for revision surgery was adjacent segment disease and intervertebral foraminal stenosis after posterolateral fixation at l2-5.It was reported that the l2-5 ps was planned to be replaced in a total of 8 screws, but due to breakage of the driver tip in this report, and although every possible means was attempted, the existing screws were too firmly fixed, so 3 screws could not be removed and replaced, and the post portion was left in the body. there was no patient symptoms reported.There were no further complications reported regarding the event.Additional information received from the manufacturer representative that there was no malfunction with the screws and it is believed that the cause was that an 8.5 mm diameter screw had been inserted and was fitting very tightly.Additional information received from the manufacturer representative that this reoperation based on the patient¿s condition.It is not related to the screw¿s fixation.
Additional Manufacturer Narrative
G2: country of event is japan.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: GENERIC INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: justin ellis ; 1800 pyramid place; memphis, TN 38132 ; +1(763)526-5677
• MDR Report Key: 50929801
• Report Number: 3003120897-2026-01646
• Device Sequence Number: 18828743
• Product Code: LXH
• UDI-Device Identifier: 00721902468810
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (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): 09/29/2026

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: 8361025
• Device Catalogue Number: 8361025
• Device Lot Number: JM04C012
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 03/01/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown