MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL; CONNECTION COMPONENT ROTATIONAL VERSION,SMALL

Model Number	16-2840/02
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The production records have been inspected and reviewed.
Event or Problem Description
During implantation it was noticed that the implant had been delivered with a plateau screw whose bushing had detached from the screw shaft due to a longitudinal crack.
Additional Manufacturer Narrative
The production records have been inspected and reviewed.Based on the investigation, the medical device problem code a " 1135 - crack" was changed to "1260 - fracture".This is the final supplemental report, the complaint is closed.
Event or Problem Description
During implantation it was noticed that the implant had been delivered with a plateau screw whose bushing had detached from the screw shaft due to a longitudinal crack.

• Brand Name: ENDO-MODEL SL
• Common Device Name: CONNECTION COMPONENT ROTATIONAL VERSION,SMALL
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 24050694
• Report Number: 3004371426-2026-00004
• Device Sequence Number: 18612806
• Product Code: KRO
• UDI-Device Identifier: 04026575359233
• UDI-Public: 04026575359233
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 16-2840/02
• Device Catalogue Number: 16-2840/02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2025
• 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