Description of Event or Problem · 1
AN ENDOSSEOUS DENTAL IMPLANT THAT WAS PACKAGED BY STRYKER INSTRUMENTS IN APRIL 1994 HAD A LABEL PLACED ON IT IN JUNE OF 1994 WHEN BICON, INC. PURCHASED THE PRODUCT LINE FROM STRYKER. THE ADHESIVE LABEL ON THE OUTER PACKAGING WAS INCORRECT. THE ACTUAL IMPLANT HAD A LENGTH OF 14.0MM BUT WAS THE LABEL PLACED ON THE PACKAGING THE TRANSITION WAS 11.0MM. THE DENTIST PURCHASED THE IMPLANT ON 10/1994 AND PLACED IT IN A PT IN 2001. THE DENTIST DRILLED AN OSTEOTOMY TOO DEEP THUS CAUSING DAMAGE TO THE PT'S INFERIOR ALVEOLAR NERVE. ACCORDING TO THE DENTIST, THE IMPLANT WAS REMOVED. THE PROTOCOL FOR THIS LABELING PROCEDURE WAS A TEMPORARY ONE AND NO LONGER ARE PRODUCTS LABELED IN THIS MANNER. RECORDS INDICATE THERE WERE ONLY FOUR IMPLANTS LABELED THIS WAY. TWO DENTAL OFFICES RECEIVED THESE IMPLANTS. ONE OFFICE IS THE ONE REPORTING THIS EVENT, AND THE OTHER HAS ATTEMPTED TO BE CONTACTED BY PHONE. THE FOUR IMPLANTS IN QUESTION WERE ALL SOLD IN 1994. MFR WAS NOT MADE AWARE OF THE EVENT UNTIL 11/2001 AND DID NOT RECEIVE A COMPLETED ADVERSE EVENTS SHEET WITH ALL RELEVANT INFO FROM CUSTOMER UNTIL LATER IN 11/2001.