MAUDE Adverse Event Report: KLS MARTIN SE & CO. KG DISTRACTION; ACTIVATION ARM

Model Number	51-410-43-09
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lots identified: 33349937, 33584030.
Event or Problem Description
It was reported the remote detach arm on the right-side distractor was secured in place.
Additional Manufacturer Narrative
H4- manufacturing dates.Lots.33349937 mfg.2020-02-05.33584030 mfg.2023-11-03.

• Brand Name: DISTRACTION
• Common Device Name: ACTIVATION ARM
• 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: 24307830
• Report Number: 9610905-2026-00008
• Device Sequence Number: 9608990
• Product Code: MQN
• UDI-Device Identifier: 00888118080936
• UDI-Public: (01)00888118080936
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010139
• Exemption Number: 2017029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 02/20/2026

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: 51-410-43-09
• Device Lot Number: SEE H11
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/17/2026
• 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: Male