MAUDE Adverse Event Report: KLS MARTIN SE & CO. KG LEVEL ONE CMF; PLATE

Model Number	50-795-26-09
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a plate broke.It was removed and replaced.
Additional Manufacturer Narrative
Correction.B5 - describe event or problem - clarification of event description.
Event or Problem Description
It was reported that a plate installed over a defect without a supporting bone or bone graft has become broken.It was removed and replaced.
Additional Manufacturer Narrative
An investigation was successfully completed.The results of the investigation have identified a known inherent risk of the device.No corrective or preventive actions are required at this time.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.

• Brand Name: LEVEL ONE CMF
• Common Device Name: PLATE
• 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 ; 9046417746
• MDR Report Key: 21381237
• Report Number: 9610905-2025-00001
• Device Sequence Number: 12879522
• Product Code: MQN
• UDI-Device Identifier: 00888118078896
• UDI-Public: (01)00888118078896
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032442
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 05/27/2025

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: 50-795-26-09
• Device Lot Number: 33602257
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/13/2025; 05/27/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 02/14/2025; 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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: Male