INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2024-00141
- Event Type
- Malfunction
- Date Received
- February 27, 2024
- Report Date
- February 27, 2024
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3: DATE OF EVENT UNKNOWN. H6 - NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. RICARDO A. LANDAZURI DEL BARRIO, EDELCIO RENDOHL DE SOUZA, ALIA OKA AL HOUCH, HELOISA F. MARAO. "REHABILITATION OF SEVERELY ATROPHIC MANDIBLE: A 3-YEAR FOLLOW-UP PROTOCOL" JOURNAL OF ORAL IMPLANTOLOGY. VOL. XLVIII /NO. SIX /2022. HTTPS://DOI.ORG/10.1563/AAID-JOI-D-20-00418. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
SUMMARY: THIS CLINICAL CASE REPORT PRESENTED A TECHNIQUE FOR RECONSTRUCTION OF SEVERELY ATROPHIC MANDIBLES IN AN ELDERLY FEMALE PATI ENT TO ALLOW THE IMPLANT-SUPPORTED PROSTHESIS PROTOCOL. THE PLACEMENT OF IMMEDIATE IMPLANTS WAS POSSIBLE BY USING AN INTRAORAL APPROACH FOR FIXATION OF A TITANIUM PLATE FOLLOWED BY GUIDED BONE REGENERATION IN ASSOCIATION WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN¿2, DEPROTEINIZED BOVINE BONE MINERAL, AND TITANIUM MESH IN A 1-STAGE SURGICAL PROCEDURE. THERE WERE NO REPORTS IN THE LITERATURE OF THIS APPROACH FOR TREATING OF SEVERELY ATROPHIC MANDIBLES. THIS CASE REPORT DESCRIBED THE TREATMENT OF A PATIENT WHOSE MANDIBLE WAS SEVERELY ATROPHIC BY FIXING A RECONSTRUCTION PLATE WITH AN INTRAORAL APPROACH IN COMBINATION WITH A VERTICAL BONE RECONSTRUCTION PROCEDURE PERFORMED SIMULTANEOUSLY WITH THE IMPLANT PLACEMENT. REPORTED EVENTS: A 72-YEAR-OLD HEALTHY WOMAN, WHO WAS EDENTULOUS FOR MORE THAN 50 YEARS, SOUGHT TREATMENT BECAUSE OF ESTHETIC AND FUNCTIONAL DISCOMFORT CAUSED BY THE MAXILLA AND MANDIBLE COMPLETE DENTURE, MAINLY REGARDING THE MANDIBULAR ONE. IN THE FACIAL ANALYSIS WITHOUT THE PROSTHESES, IT WAS OBSERVED THAT HER FACE HAD AN AGED APPEARANCE WITH REDUCED VERTICAL DIMENSION. CONE-BEAM COMPUTERIZED TOMOGRAPHY (CBCT) SHOWED AN ANTERIOR MANDIBULAR HEIGHT OF LESS THAN 3 MM AND BILATERAL EXPOSURE OF THE INFERIOR ALVEOLAR NERVES. INITIALLY, FIXATION OF THE MANDIBLE WAS PLANNED USING A 2.4-MM RECONSTRUCTION PLATE OF 2.4 MM (TORIDE) TO BE ADAPTED TO THE BASE OF THE MANDIBLE TO PREVENT POSSIBLE FRACTURES DUE TO THE LIMITED AVAILABILITY OF BONE TISSUE. NEXT, A PROTOTYPE OF THE MANDIBLE WAS MADE BASED ON CBCT SLICES TO ALLOW ADAPTATION AND MODELING OF THE PLATE BEFORE THE SURGICAL PROCEDURE AND ITS SUBSEQUENT FIXATION USING AN INTRAORAL APPROACH. PROTOTYPING WAS ALSO USED TO CREATE A SURGICAL GUIDE FOR PLACEMENT OF THE IMPLANTS. THE PATIENT WAS HOSPITALIZED FOR SURGERY UNDER GENERAL ANESTHESIA. . AFTER INTRAVENOUS SEDATION, INTRAORAL ANESTHESIA WAS PERFORMED AT THE RETROMOLAR REGION CLOSE TO THE INFERIOR ALVEOLAR NERVE AND COMPLEMENTED WITH INFILTRATIVE ANESTHESIA IN THE ENTIRE MANDIBULAR RIDGE WITH 4% ARTICAINE WITH EPINEPHRINE. 2.4-MM RECONSTRUCTION PLATE (TORIDE) WAS FIXED ON THE BASE OF THE MANDIBLE WITH 10 SCREWS. TWO EXTRA-SHORT IMPLANTS WERE PLACED BILATERALLY IN THE POSTERIOR REGION, WHEREAS 3 IMPLANTS OF MM WERE PLACED IN THE ANTERIOR MANDIBULAR REGION, THAT IS, BETWEEN THE MENTAL FORAMINA IN THE REMAINING BONE. NEXT, A SIMULTANEOUS 3-DIMENSIONAL BONE AUGMENTATION WAS PERFORMED, COVERING 6 MM OF THE EXPOSED THREADS OF THE IMPLANTS BY USING A SHAPED TITANIUM MESH IN ASSOCIATION WITH RHBMP-2 AND DEPROTEINIZED BOVINE BONE MINERAL. THE TISSUES WERE SUTURED IN PLANES USING ABSORBABLE THREAD INTERRUPTED SUTURE IN THE DEEP PLANE, AND CONTINUOUS STITCHES IN THE OUTERMOST PLANE TO KEEP THE FLAP PASSIVE AND COMPLETELY FREE OF TENSION. AFTER THE SURGERY, THE MEDICATIONS PRESCRIBED WERE ANTIBIOTICS AND ANTI-INFLAMMATORIES AND SOFT DIET WAS RECOMMENDED. THE PATIENT CONTINUED USING THE OLD PROSTHESES PROPERLY ADJUSTED AND INTERNALLY RELIEVED UNTIL THE COMPLETE HEALING PROCESS. EIGHT MONTHS AFTER THE SURGERY, A SMALL EXPOSURE OF THE TITANIUM MESH WAS CLINICALLY OBSERVED BUT WITH NO INFECTION. NEXT, THE FLAP WAS DISPLACED FOR SURGICAL REMOVAL OF THE TITANIUM MESH, HEALING CAPS WERE PLACED, AND AN EXTENSIVE NEW BONE FORMATION WAS OBSERVED. BONE AUGMENTATION HEIGHT (6¿7 MM) AND THICKNESS (5¿6 MM) WAS SHOWN ON CBCT AND PANORAMIC RADIOGRAPH AROUND ALL THE IMPLANTS IN THE ANTERIOR REGION OF THE MANDIBLE. AFTER 1 MONTH, ABUTMENTS WERE PLACED ONTO THE IMPLANTS AND A TRANSFER IMPRESSION WAS PERFORMED. NEXT, RECORD BASES WITH OCCLUSION RIMS WERE MADE AND ADJUSTED ACCORDING TO ESTHETIC AND FUNCTIONAL PRINCIPLES. A CENTRIC RELATION INTEROCCLUSAL RECORD WAS OBTAINED, AND THE CASTS WERE MOUNTED ON A SEMI ADJUSTABLE ARTICULATOR. ARTIFICIAL TEETH WERE ARRANGED AND FULL-ARCH IMPLANT SUPPORTED PROSTHESES AND THE MAXILLA COMPLETE DENTURE WERE INSTALLED. BOTH MAXILLARY AND MANDIBULAR PROSTHESES WERE MADE WITH HEAT-POLYMERIZED ACRYLIC RESIN AND THE BILATERAL BALANCED OCCLUSION WAS ADJUSTED. THE PATIENT HAD NO TECHNICAL OR BIOLOGICAL COMPLICATION DURING THE 3-YEAR FOLLOW-UP PERIOD AND REPORTED BOTH ESTHETIC AND FUNCTIONAL SATISFACTION WITH THE PROSTHETIC REHABILITATION. THE CBCT SHOWED MAINTENANCE OF THE BONE VOLUME AROUND ALL IMPLANTS IN THE REGION OF THE SIMULTANEOUS 3-DIMENSIONAL BONE AUGMENTATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1669696 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | MSB_UNK_BMP2_ACS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female |