MAUDE Adverse Event Report: LiNA Medical ApS LiNA Gold Loop

Model Number	EL-200-8
Medical Device Problem Code	Fracture (1260)
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
Narrative provided by the distributor: "allegedly, the photo below shows the loop after it was damaged".
Additional Manufacturer Narrative
(b)(6)medical is waiting for product back for investigation.

• Brand Name: LiNA Gold Loop
• Common Device Name: LiNA Gold Loop
• Manufacturer (Section D): LiNA Medical ApS; formervangen 5; glostrup, 2600 ; DA 2600
• Manufacturer (Section G): LiNA Medical Polska Sp. z o.o.; rolna 8a; sady; tarnowo podgórne, 62-08 0; PL 62-080
• Manufacturer Contact: monika lewandowska ; formervangen 5; glostrup, 2600 ; DA 2600
• MDR Report Key: 50880735
• Report Number: 3007699067-2026-00001
• Device Sequence Number: 15909123
• Product Code: KNF
• UDI-Device Identifier: 05708265001323
• UDI-Public: (01)05708265001323(17)280615(11)250616(10)2525005
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: EL-200-8
• Device Lot Number: 2525005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown