MY3D PERSONALIZED SOLUTIONS
Received Aug 9, 2024
Report 3013450937-2024-00266 · MDR key 19951308
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
62 YR · Female
- Unspecified Infection
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED ON 11 JULY 2024 BY A FIELD REPRESENTATIVE THAT A PATIENT IMPLANTED WITH AN ONKOS MY3D PERSONALIZED SOLUTIONS CUSTOM GLENOID IMPLANT HAS AN ALLEGED INFECTION. IT WAS REPORTED THAT THE IMPLANT WILL BE EXPLANTED; HOWEVER, THE DATE OF THE SCHEDULED REVISION PROCEDURE IS UNKNOWN. ALL PRODUCTION RECORDS WERE REVIEWED AND NO MANUFACTURING ABNORMALITIES WERE OBSERVED. IT WAS REPORTED BY THE FIELD REPRESENTATIVE THAT THE STEAM STERILIZATION PARAMETERS WERE FOLLOWED AT THE HOSPITAL PER THE RESPECTIVE DEVICE IFU. THE ROOT CAUSE OF THIS EVENT WAS NOT DETERMINED. BASED ON THE REVIEW OF DEVICE HISTORY RECORDS, THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE ALLEGED INFECTION WAS NOT LIKELY RELATED TO THE DESIGN OR MANUFACTURE OF THE IMPLANTED ONKOS DEVICE.
Additional Manufacturer Narrative
ADDITIONAL DETAILS ARE UNKNOWN AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WHO WAS IMPLANTED WITH AN ONKOS CUSTOM GLENOID IMPLANT WILL BE RECEIVING A REVISION PROCEDURE DUE TO AN ALLEGED INFECTION. THE DATE OF REVISION IS NOT KNOWN AT THIS TIME. THIS EVENT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY DUE TO THE UPCOMING REVISION PROCEDURE. THIS REPORT CAPTURES THE CUSTOM GLENOID IMPLANT.