MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC PROLOCK CROSSLINK; SCREWDRIVER

Model Number	5482304
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2025
Type of Reportable Event	Malfunction
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 spinal procedure involving the crosslink, the driver broke while attempting to tighten the gold screw with the breakoff driver, and was unable to loosen screws for crosslink removal.The crosslink was initially placed over the rods with provisional tightening tools, and the old screws had been backed off to facilitate placement.A separate instrument was used to unscrew the center blue screw.No patient complications have been reported as a result of this event.Additional information was received from the manufacturer representative that the case was a t7-t11 stabilization case.As the pro lock driver was tightening the gold screw on the crosslink, the gold screw wasn¿t moving.The gold set screw had an issue and wouldn¿t advance.It was unable to advance the screw in the crosslink.
Additional Manufacturer Narrative
G2: country of origin - australia 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: PROLOCK CROSSLINK
• 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: 21992920
• Report Number: 1030489-2025-01932
• Device Sequence Number: 4311903
• Product Code: HXX
• UDI-Device Identifier: 00643169641617
• UDI-Public: 00643169641617
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/09/2025

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: 5482304
• Device Catalogue Number: 5482304
• Device Lot Number: UNKNOWN
• 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: 04/19/2025
• Initial Report FDA Received Date: 05/09/2025
• 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