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

Model Number	GA04041
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A patient in (b)(6) 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.
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 12247
• MDR Report Key: 7731138
• Report Number: 3002949614-2018-00001
• Device Sequence Number: 920670
• 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
• PMA/510(K) Number: K120978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• 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
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 11/08/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 07/30/2018
• 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