MAUDE Adverse Event Report: KLS Martin Manufacturing LLC IPS; IMPLANT

Model Number	60-000-69-09-LP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lots identified: 8000251864.8000251865.
Event or Problem Description
It was reported the ips implants have become fractured resulting in a mobile maxilla following approximately 4 months of implantation.They were removed and replaced.

• 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 ; +1(904)641-7746
• MDR Report Key: 23728211
• Report Number: 1000525271-2025-00005
• Device Sequence Number: 10258800
• Product Code: JEY
• 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: 2025
• 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
• Report Date (Section B): 09/03/2026

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: 60-000-69-09-LP
• Device Lot Number: SEE H11
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2025
• 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: 46 YR
• Patient Sex: Male