MAUDE Adverse Event Report: KLS-MARTIN L.P. IPS; DISTRACTOR

Model Number	60-008-92-09
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lots.26007309.26007311.
Event or Problem Description
It was reported that the ips midface distractors did not advance as expected, resulting in difficulties during removal.They were removed and replaced with alternate fixation products.Distractors were intact and undamaged upon explant.

• Brand Name: IPS
• Common Device Name: DISTRACTOR
• Manufacturer (Section D): KLS-MARTIN L.P.; 11201 st. johns ind. pkwy s; jacksonville FL 32246
• 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: 25412536
• Report Number: 1000525271-2026-00024
• Device Sequence Number: 5939057
• Product Code: MQN
• UDI-Device Identifier: 00888118129833
• UDI-Public: (01)00888118129833
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K220050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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
• Report Date (Section B): 05/07/2026

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: 60-008-92-09
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 8 YR
• Patient Sex: Male
• Patient Weight: 23 KG