OMNIPORE SURGICAL IMPLANT
Received Feb 1, 2023 · Event occurred Nov 21, 2022
Report 3009383407-2022-00002 · MDR key 16278757
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
6 YR · Male
- Post Operative Wound Infection
- Post Operative Wound Infection
Narrative
Description of Event or Problem
ACCORDING TO THE INITIAL REPORT, A MICROTIA PATIENT HAD SURGERY ON (B)(6) 2022 AND NOW HAS A FUNGAL INFECTION OF HIS IMPLANT. THE PATIENT WILL UNDERGO SURGICAL REVISION.
Additional Manufacturer Narrative
MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE TO NO AVAIL. THE PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION. THE LOT NUMBER WAS TRACED, AND A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES IDENTIFIED DURING THE PROCESSING OF THE IMPLANT. A REVIEW OF THE STERILITY RESULTS WAS CONDUCTED. ALL STERILITY SPECIFICATIONS MET REQUIREMENTS UPON PRODUCT RELEASE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A REVIEW OF THE RISK ANALYSIS WAS PERFORMED. NON-STERILE PRODUCTS ARE LISTED AS A SERIOUS HAZARD. THE STERILITY CYCLE PARAMETERS MUCH BE MET AS WELL AS THE VOLUME OF PYROGENS ON THE DEVICE. IN THIS CASE, ALL STERILITY PARAMETERS WERE MET AND THE PYROGEN RESULTS WERE WELL WITHIN RANGE. CONCLUSIVELY, INFECTION IS A KNOWN INHERENT RISK OF ANY SURGICAL PROCEDURE. THE INSTRUCTIONS FOR USE LIST SUPERFICIAL AND/OR DEEP INFECTION AS A POSSIBLE EFFECT.
Description of Event or Problem
ACCORDING TO THE INITIAL REPORT, A MICROTIA PATIENT HAD SURGERY ON (B)(6) 2022 AND NOW HAS A FUNGAL INFECTION OF HIS IMPLANT. THE PATIENT WILL UNDERGO SURGICAL REVISION.
Additional Manufacturer Narrative
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
Remedial action
- Replace