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

Model Number	60-000-65-09-LP
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a portion of an ips plate over a graft junction fractured three months after implant due to loss of osseointegration at the junction.It was removed and the rest of the plate remains implanted.
Additional Manufacturer Narrative
An investigation was successfully completed.The results of the investigation have identified a known inherent risk of the device.No corrective or preventive actions are required 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: 19996231
• Report Number: 3014483751-2024-00002
• Device Sequence Number: 15544544
• Product Code: JEY
• UDI-Device Identifier: 00888118140364
• UDI-Public: (01)00888118140364
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 60-000-65-09-LP
• Device Lot Number: 8000158976
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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: 63 YR
• Patient Sex: Male