MAUDE Adverse Event Report: KLS MARTIN MANUFACTURING, LLC 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 MANUFACTURING, LLC; 11228 st. johns ind. pkwy. s; jacksonville FL 32246
• Manufacturer (Section G): KLS MARTIN MANUFACTURING, LLC; 11228 st. johns ind. parkway s; jacksonville FL 32246
• Manufacturer Contact: melissa bachorski ; p.o. box 16369; jacksonville, FL 32245 ; 9046417746
• MDR Report Key: 21588141
• Report Number: 3014483751-2025-00001
• Device Sequence Number: 13128493
• Product Code: JEY
• UDI-Device Identifier: 00888118140357
• UDI-Public: (01)00888118140357
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• 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
• 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