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

Model Number	60-000-72-09-LP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that ips implants were removed due to unknown reasons.
Additional Manufacturer Narrative
Possible lots identified: 8000204748, 8000204749, 8000204750, 8000204751.

• 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: 23855152
• Report Number: 1000525271-2025-00007
• Device Sequence Number: 5030180
• 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: 2024
• 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): 08/25/2026

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: 60-000-72-09-LP
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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: 17 YR
• Patient Sex: Female