MAUDE Adverse Event Report: KLS Martin SE & Co. KG DISTRACTION; DISTRACTOR EXTENSION CARDANIC

Model Number	51-401-91-09
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an activation arm became fractured from the distractor following approximately 6 weeks of implantation.The activation arm was removed and replaced.

• Brand Name: DISTRACTION
• Common Device Name: DISTRACTOR EXTENSION CARDANIC
• Manufacturer (Section D): KLS Martin SE & Co. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer (Section G): KLS Martin SE & Co. KG; kolbinger strasse 10; muehlheim/donau, 78570 ; GM 78570
• Manufacturer Contact: melissa bachorski ; p.o. box 16369; jacksonville, FL 32245 ; +1(904)641-7746
• MDR Report Key: 24469116
• Report Number: 9610905-2026-00017
• Device Sequence Number: 18699585
• Product Code: MQN
• UDI-Device Identifier: 00888118080745
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K010139
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 51-401-91-09
• Device Lot Number: Unknown
• Date Returned to Manufacturer: 02/19/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown