MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. 5.5/6.0MM OPEN EXTENDER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5485900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient having spinal therapy.It was reported that during a posterior spinal fusion procedure utilizing advanced deformity instruments (adis) to facilitate reduction of a 6.0 cocr rod into pedicle screws at levels t3 to l4, one adi fractured during the tightening process as the reducer was being secured to the pedicle screws.A fragment of the instrument was temporarily retained and identified intraoperatively.Intraoperative x-ray imaging was conducted to locate the fractured fragment, which was subsequently removed prior to wound closure.The procedure was ultimately successful, and no further complications were reported aside from the additional operative time and imaging.Additional information was received from the manufacturer representative that the total procedure time was extended by approximately 20 minutes.
Additional Manufacturer Narrative
Radiographic image review indicated that, intra-op xray shows, a small metallic fragment is present next to one of the screw tulips as described.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 of product: 5485900, lot:ct20d031 visual and microscopic examination identified that the one of the tabs on the tip of the extender has broken off.The fracture is consistent with excessive force.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: 5.5/6.0MM OPEN EXTENDER
• 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: 23800278
• Report Number: 3003120897-2025-00732
• Device Sequence Number: 15375158
• Product Code: LXH
• UDI-Device Identifier: 00643169064287
• UDI-Public: (01)00643169064287(11)200522(10)CT20D031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 5485900
• Device Catalogue Number: 5485900
• Device Lot Number: CT20D031
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 02/03/2026; 02/26/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/24/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• 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 Age: 16 YR
• Patient Sex: Unknown
• Patient Weight: 68 KG