MAUDE Adverse Event Report: MERETE GMBH OSTEOBRIDGE IKA; OSTEOBRIDGE INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM

Model Number	GA04041
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient have had implanted an ika system.The spacer of the system seems to be rotated about 90°.It was diagnosed in (b)(6) 2017.The system was very well implanted and although it was rotated it worked sufficient so far that the surgeon decides to have a close follow-up and wait to revise the system.The patient have had no pain and walked well with the rotated system.In (b)(6) 2018 the surgeon decided to remove the system to avoid a permanent inappropriate load.During revision the nails have shown to be ingrown well so that the surgeon decided to just change the spacer.

• Brand Name: OSTEOBRIDGE IKA
• Common Device Name: OSTEOBRIDGE INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
• Manufacturer (Section D): MERETE GMBH; alt-lankwitz 102; berlin, berlin 12247 , GM; GM 12247, GM
• MDR Report Key: 14274287
• Report Number: 3012147813-2022-00002
• Device Sequence Number: 4439567
• Product Code: HSB
• UDI-Device Identifier: 04048266078735
• UDI-Public: (01)04048266078735(17)220118(10)MS1709836
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2017
• Report Date (Section F): 11/08/2017

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: Lay User/Patient
• Device Model Number: GA04041
• Device Catalogue Number: GA04041
• Device Lot Number: MS1709836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/08/2017
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 11/08/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male