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

Model Number	2942016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having oblique lateral lumbar interbody fusion spinal therapy for lumbar disc herniation.It was reported that when using this tool to treat the intervertebral disc, a fracture occurred at the distal tip.There were no broken fragments left inside the patient and no further complications reported regarding the event.Additional information was received from regulatory body that the surgery time and risk of infection was extended due to fractured tip.The patient underwent lateral anterior lumbar discectomy with bone graft fusion and internal fixation.During the procedure, while using a lumbar curette, the tip of the curette fractured and fell into the body cavity.After more than 20 minutes of exploration and removal, the fragment was completely retrieved.This significantly prolonged the operation time and increased the risk of intraoperative infection.Postoperatively, anti-infection treatment was strengthened.
Additional Manufacturer Narrative
G2: country of origin is china.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: DIRECT LATERAL INSTRUMENTS
• 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 ; 7635265677
• MDR Report Key: 25662323
• Report Number: 3003120897-2026-01110
• Device Sequence Number: 10406877
• Product Code: LXH
• UDI-Device Identifier: 00613994866691
• UDI-Public: (01)00613994866691(11)190520(10)NM19D026
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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 Model Number: 2942016
• Device Catalogue Number: 2942016
• Device Lot Number: NM19D026
• 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: 06/02/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 05/20/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female