MAUDE Adverse Event Report: KLS MARTIN MANUFACTURING LLC IPS; IMPLANT

Model Number	60-000-72-09-LP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot numbers identified: 8000199042, 8000199043.
Event or Problem Description
It was reported ips plates were found to be fractured approximately 6 months post procedure possibly due to a mobile maxilla.It was removed and replaced.
Additional Manufacturer Narrative
An investigation was successfully completed.The results of the investigation have identified no manufacturing issues, no design issues and/or corrective actions necessary 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.Lots identified 8000199042.8000199043.

• Brand Name: IPS
• Common Device Name: IMPLANT
• Manufacturer (Section D): KLS MARTIN MANUFACTURING LLC; 11228 st. johns ind. pkwy s; jacksonville FL 32246
• Manufacturer (Section G): KLS MARTIN MANUFACTURING LLC; 11228 st johns indust. pkwy s; jacksonville FL 32246
• Manufacturer Contact: melissa bachorski ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 21938470
• Report Number: 1000525271-2025-00003
• Device Sequence Number: 7985720
• Product Code: JEY
• UDI-Device Identifier: 00888118140425
• UDI-Public: (01)00888118140425
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: 60-000-72-09-LP
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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 Age: 43 YR
• Patient Sex: Male