FOREIGN ARTICLE APG010

Additional Manufacturer Narrative

ADDITIONAL INFORMATION/CORRECTION: B5 - DESCRIPTION UPDATED D SECTION - PRODUCT UPDATED, DEVICE RECEIVED DATE ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3,, THIS EVENT IS CONSIDERED NO LONGER REPORTABLE FOR THE FOLLOWING REASONS: - NO SERIOUS PUBLIC HEALTH THREAT / FALSIFIED DEVICE - NO SERIOUS INCIDENT.

Description of Event or Problem

UPDATE: ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE COMPLAINED PRODUCT WAS NON-AESCULAP.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH DO655R HEMINGWAY SHARP SPOON DBL.END.170MM. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CURRETTE FRACTURED DURING A DENTAL PROCEDURE AND ALVEOLAR CURETTAGE. AN X-RAY WAS TAKEN AS WELL AS A SEARCH OF THE BACK TABLE AND SURGICAL SITE, AND THE FRAGMENT WAS RETRIEVED. THIS CAUSED AN UNSPECIFIED SURGICAL DELAY. A PICTURE CONFIRMED THE FRACTURE. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - ADVERSE EVENT (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS ADVERSE EVENT WAS BASED ON THE PATIENT HARM, ADDITIONAL MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS NOT AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO.(B)(4).

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.