MAUDE Adverse Event Report: KLS-MARTIN LP IPS; IMPLANT

Model Number	60-000-64-09-LP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an ips implant and fibula graft was removed and not replaced.There is no allegation of a product issue at the time of removal.

• Brand Name: IPS
• Common Device Name: IMPLANT
• Manufacturer (Section D): KLS-MARTIN LP; 11201 st. johns ind. pkwy; 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: 21588161
• Report Number: 1000525271-2025-00001
• Device Sequence Number: 9457206
• Product Code: JEY
• UDI-Device Identifier: 00888118140357
• UDI-Public: (01)00888118140357
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K210731
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 02/26/2025

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: 60-000-64-09-LP
• Device Lot Number: 8000220619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2025
• 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: 71 YR
• Patient Sex: Female