MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. SOLERA VOYAGER 5.5; SCREWDRIVER

Model Number	6550004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/19/2026
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 l5/6/s tlif (tr ansforaminal lumbar interbody fusion) it was reported that after insertion of the l6 right screw under mazor, additional insertion was attempted manually using g170059 (cannulated ratchet handle) + 6555004 (sv56 ball-end bone screwdriver), but did not advance due to bone sclerosis; the handle was changed to 836-009 (ratchet t-handle) and additional manual insertion was attempted, during which the tip of 6555004 (sv56 ball-end bone screwdriver) fractured and remained inside the screw.There was no patient symptoms reported.There were no further complications reported regarding the event.3 apr 2026, update received: postoperatively, the patient experienced numbness in the right lower extremity.According to the operating surgeon, this was attributed to intervertebral foraminal stenosis caused by excessive compression related to the prior procedure.On (b)(6) 2026, a revision procedure was performed, which included rod loosening and repeat decompression.Additional decompression was carried out, and the rod was re-secured using new set screws.During the revision procedure, the previously fractured tip of the sv56 ball-end bone screwdriver (product 655004) at the right l6 screw was removed and retrieved from the body prior to rod fixation.Following retrieval, rod fixation was completed and the procedure concluded.No malfunction of the voyager 5.5/6.0 implant product has been reported.The reported numbness and revision were confirmed to be related to the patient¿s condition and prior procedure, and not due to a medtronic rod malfunction.

• Brand Name: SOLERA VOYAGER 5.5
• Common Device Name: SCREWDRIVER
• 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: 24857409
• Report Number: 3003120897-2026-00684
• Device Sequence Number: 15770847
• Product Code: HXX
• UDI-Device Identifier: 00643169754515
• UDI-Public: (01)00643169754515(11)170922(10)KH17A087
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: 6550004
• Device Catalogue Number: 6550004
• Device Lot Number: KH17A087
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2017
• 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