SST EZ SPHERE - 22MM
Report
- Report Number
- 0008010177-2017-00274
- Event Type
- Injury
- Date Received
- November 1, 2017
- Date of Event
- September 19, 2017
- Report Date
- April 18, 2018
- Manufacturer
- STRYKER ORTHOBIOLOGICS-MALVERN
- Product Code
- FWP
- PMA / PMN Number
- K922489
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
DUE TO THE NATURE OF THE COMPLAINT, THE OBSERVATION STATED IN THE REPORTED EVENT COULD NOT BE CON- FIRMED. FOR INFECTION COMPLAINTS EXPANDED INVESTIGATIONS WERE PERFORMED TO ASSURE THAT NEITHER THE COM- PLAINED DEVICE NOR ALL RELATED MANUFACTURING PROCESS STEPS (E.G. ENVIRONMENTAL MONITORING, STERILIZATION VALIDATIONS TESTS) HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. IT WAS ADDITIONALLY EVALUATED IF THE RISK ASSUMPTIONS IN THE RELATED FMEA ARE IN CORRESPONDENCE WITH THE REPORTED EVENT. WITHIN THESE EXPANDED INVESTIGATION NO INDICATION WAS FOUND FOR ANY SYSTEMATIC, DESIGN OR MANUFACTURING RELATED ISSUE. IN ORDER TO OBTAIN MORE DETAILED INFORMATION ABOUT THE EVENT AND THE OCCURRED INFLAMMATION AN INFECTION CHECKLIST IN COMBINATION WITH SOME FURTHER QUESTIONS WERE SENT SEVERAL TIMES TO THE SALES REP. AS A RESPONSE IT WAS CONFIRMED THAT ALL PATIENTS HAVE RECOVERED AND ARE NOW FINE AGAIN. IN A FINAL PHONE CALL BY THE REGIONAL SALES MANAGER ON (B)(6) 2017 IT WAS ADDITIONALLY STATED THAT NO FURTHER ANSWERS WILL / CAN BE PROVIDED BY THE CLINIC. THE PROVIDED INFORMATION WAS NOT SUFFICIENT TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. WITH RESPECT TO A FORMER INFECTION COMPLAINT FOR A MEDPOR PRODUCT, THE FOLLOWING INFORMATION WAS PROVIDED BY THE R&D MEDPOR EXPERT (VICE PRESIDENT OF CONCEPT DEVELOPMENT ): ¿USUALLY, AN INFECTION AT A MEDPOR IMPLANT SITE IS THOUGHT TO BE CAUSED BY EITHER CONTAMINATION OF THE IMPLANT DURING THE INITIAL SURGERY, ESPECIALLY FROM ORAL MUCOSA IF IT IS AN INTRAORAL APPROACH, OR LATER CONTAMINATION THROUGH A SURGICAL WOUND DEHISCENCE OR EXPOSURE OF THE IMPLANT DUE TO BREAKDOWN OF THE OVERLYING TISSUE.¿ ALL GIVEN INFORMATION WERE FORWARDED TO THE STRYKER HEALTH CARE PROFESSIONAL, WHO AGREED WITH THE R&D MEDPOR EXPERT. BASED ON THE INVESTIGATION, THE DHR REVIEW OF THE RELATED MANUFACTURING AND QUALITY DOCUMENTS AND THE RESULTS FROM THE EXPANDED INVESTIGATION AT THE MANUFACTURER SITE THERE IS NO INDICATION FOR A NOT CORRECTLY WORKING PRODUCT OR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.
IT WAS REPORTED BY HOSPITAL PHARMACIST THROUGH A COMPANY REPRESENTATIVE THAT A PATIENT DEVELOPED A POSSIBLE POST-SURGICAL INFECTION RELATED TO A MAJOR ORBITAL INFLAMMATORY SYNDROME AFTER A SURGICAL PROCEDURE WITH AN IMPLANT. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY WITHOUT A DELAY. IT WAS REPORTED THE PATIENT RETURNED TO THE HOSPITAL AND ADDITIONAL MEDICAL INTERVENTION WAS ADMINISTERED.
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE STILL IMPLANTED.
IT WAS REPORTED BY HOSPITAL PHARMACIST THROUGH A COMPANY REPRESENTATIVE THAT A PATIENT DEVELOPED A POSSIBLE POST-SURGICAL INFECTION RELATED TO A MAJOR ORBITAL INFLAMMATORY SYNDROME AFTER A SURGICAL PROCEDURE WITH AN IMPLANT. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY WITHOUT A DELAY. IT WAS REPORTED THE PATIENT RETURNED TO THE HOSPITAL AND ADDITIONAL MEDICAL INTERVENTION WAS ADMINISTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 773783 | SST EZ SPHERE - 22MM | IMPLANT | FWP | STRYKER ORTHOBIOLOGICS-MALVERN | A1702029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |