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

Model Number	60-000-67-09-LP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	08/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a mandible plate broke 10 weeks after implant secondary to a non-union with patient involvement.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.

• 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: 20186013
• Report Number: 1000525271-2024-00005
• Device Sequence Number: 8249987
• Product Code: JEY
• UDI-Device Identifier: 00888118140388
• UDI-Public: (01)00888118140388
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/25/2025

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: 60-000-67-09-LP
• Device Lot Number: 8000173615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2024
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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: 22 YR
• Patient Sex: Male