BRUXZIR SCREW RETAINED CROWN

Additional Manufacturer Narrative

THE DEVICE WAS NOT AVAILALBE FOR RETURN IT WAS REPORTED THAT THE PATIENT'S DENTAL RECORDS DID NOT CONTAIN ANY DEVICE IDENTIFIERS, STICKERS, LOT NUMBER, NOR CATALOG NUMBERS. THEREFORE, A REVIEW OF OUR DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED. DURING OUR INVESTIGATION OF HISTORICAL INFORMATION, IT WAS FOUND THAT PER THE DOCTOR'S PRESCRIPTION A STRAUMANN SCREW RETAINED CROWN WAS FABRICATED FOR THE PATIENT USING STRAUMANN PARTS IN (B)(6) 2017. WITHOUT PHYSICAL ANALYSIS OF THE DEVICE, WE ARE UNABLE TO DETERMINE ROOT CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPOT WILL BE SUBMITTED. THIS IS THE SECOND OF TWO COMPLAINTS FOR THE SAME PATIENT, RELATED MDR NUMBER: 3011649314-2025-00140. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE BRUXZIR SCREW RETAINED CROWN REPEATEDLY CAME LOOSE WHICH CAUSED "FRICTION TO THE GUM LINE". IT WAS ALSO ALLEGED THAT THE CROWN "BROKE OFF "MULTIPLE TIMES, "OVER-TORQUING THE ABUTMENT". IT IS FUTHER ALLEDGED THAT "OVERALL TRAUMA CENTRALLY LOCATED TO THAT TOOTH AREA CAUSED TWO ABSCESSES IN THE INTERPROXIMAL TISSUE OF #30/31". INFORMATION RECEIVED; I AM LOOKING TO FILE A FORMAL COMPLAINT AGAINST GLIDEWELL LABORATORIES ON BEHALF OF MY LATE FATHER. (B) (6). MY FATHER WAS A PATIENT OF (B)(6), DMD ("DR. (B)(6)") (B)(6) WHO USED GLIDEWELL LABORATORIES (NEWPORT BEACH, CA) TO MANUFACTURE A STRAUMANN BRAND ABUTMENT + CROWN FOR MY FATHER'S TOOTH #30 STRAUMANN DENTAL IMPLANT POST (HARDCOPY LAB ORDER WAS SENT ON (B)(6) 2015). GLIDEWELL LABORATORIES PROVIDED AN INFERIOR ABUTMENT WHICH PROVED TO FAIL MULTIPLE TIMES IN MY FATHER'S MOUTH. THEY DID FOLLOW THE (B)(6) 2015 LAB ORDERS WHICH SPECIFICALLY MENTIONED "USE STRAUMANN PARTS". THE ABUTMENT REPEATEDLY BECAME LOOSE OVER THE COURSE OF APPROX. 2.5 YEARS WHICH CAUSED FRICTION TO THE GUMLINE. BREAKING OFF THE CROWN MULTIPLE TIMES, OVER-TORQUING THE ABUTMENT AND THE OVERALL TRAUMA CENTRALLY LOCATED TO THAT TOOTH AREA CAUSED 2 ABSCESSES IN THE INTERPROXIMAL TISSUE OF #30/31 TO DEVELOP AS A RESULT (FIRST IDENTIFIED ON (B)(6) 2018). AFTER REPEATED FAILURE, STRAUMANN (ABUTMENT MANUFACTURER), SENT THEIR REPRESENTATIVE ((B)(6)) TO DR. (B)(6) OFFICE TO VISUALLY INSPECT THE COMPONENT ((B)(6) 2017). EXTRACTED FROM P. (B)(6) OF DENTAL CHART - "PATIENT PRESENTS FOR A NEW FINAL IMPLANT IMPRESSION OF TOOTH #30, IMPLANT TYPE STRAUMANN. STRAUMANN REP (B)(6) HERE BECAUSE OF CONTINUED ISSUES WITH THIS CROWN[?] PATIENT STATES HE DOES NOT WANT TO BE NUMB FOR THIS PROCEDURE. ATTEMPT TO ACCESS SCREW LOOSENED BY DR (B)(6). REMOVE BRUXZIR CROWN. ACCESS AND REMOVE SCREW AND ABUTMENT. (B)(6) INFORM DR. NOT AUTHENTIC STRAUMANN ABUTMENT. (B)(6) WILL SEND ABUTMENT FOR SCREW RETAINED IMPLANT TO SEND WITH CASE. PLACE IMPRESSION USING LIGHT AND MEDIUM BODY MATERIAL[?]" ON (B)(6) 2017 A PHONE CALL NOTE IN CLINICAL NOTES INDICATED "SPOKE WITH DAT IN IMPLANT DEPARTMENT REUSING GENUINE STRAUMANN PARTS. INFORM HIM SENDING VARIOBASE SENT TO US FROM THE COMPANY. (B)(6) CASE ID # IS (B)(4)". (B)(6) - DENTAL CHART). NOTE: NARRATIVE OF PHONE CONVERSATION BETWEEN DR. (B)(6) AND (B)(6) WAS NEVER INCLUDED IN DENTAL RECORD, ON (B)(6) 2017 - DR. (B)(6) LAB ORDER TO GLIDEWELL LABORATORIES FOR TOOTH #30 INDICATED "ATTN: (B)(6) #30 IMPLANT REDO DR. EMAIL YOU ABOUT THIS CASE. REMAKE AS SCREW RETAINED ABUT + CRN WITH ENCLOSED STRAUMANN ABUTMENT X-RAY AND SURG REPORT THANKS" (STRAUMANN IS MISSPELLED ON LAB ORDER). (B)(6) - LAB ORDERS. NOTE: COPY OF EMAIL COMMUNICATION BETWEEN DR. (B)(6) AND (B)(6) WAS NEVER INCLUDED IN DENTAL RECORD ON (B)(6) 2017, FINAL STRAUMANN ABUTMENT + CROWN FOR TOOTH #30 WAS PLACED BY DR. (B)(6). NOTE: ATTORNEY (B)(6) HAS THIS PHYSICAL IMPLANTED TOOTH (IT FELL OUT PRIOR TO SURGERY), HOWEVER, WE BELIEVE IT IS A STRAUMANN ABUTMENT + CROWN AS (B)(6) PROVIDED IT. THE INFERIOR ABUTMENT WAS DISCARDED BY DR. (B)(6). AT THIS TIME, THE ONLY PERSON WHO WAS ABLE TO CONFIRM THE AUTHENTICITY OF THE ABUTMENT WAS (B)(6), THERE WERE NO ABUTMENT MANUFACTURER DETAILS IN THE DENTAL RECORD (NO IDENTIFIER STICKERS, LOT OR CATALOG NUMBERS WERE FOUND). ATTACHED PDF TITLED "(B)(6) - FORMAL COMPLAINT AGAINST GLIDEWELL LABORATORIES. PDF" OUTLINES THE COMPREHENSIVE SEQUENCE OF EVENTS THAT OCCURRED UNDER DR. (B)(6) CARE. I'VE ALSO ATTACHED THE PHOTOS AND OTHER DOCUMENTS TO SUPPORT THE EXTRACTED REFERENCED PAGES. (B)(6) DATE OF DEATH - (B)(6) 2022 (UNABLE TO INPUT IN #2 ABOVE).