DYMIC
Report
- Report Number
- 3005990499-2024-70090
- Event Type
- Injury
- Date Received
- January 22, 2024
- Date of Event
- November 8, 2023
- Report Date
- January 22, 2024
- Manufacturer
- KEYSTONE DENTAL, INC.
- Product Code
- DZE
- UDI-DI
- D76821700090
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
KEYSTONE DENTAL INC. PROVIDES LABELING WITH ALL IMPLANTS. FAILURE TO OSSEOINTEGRATE AND LOSS OF OSSEOINTEGRATION (IMPLANT MOBILITY) IS IDENTIFIED AS AN ADVERSE REACTION AND IDENTIFIED IN THE LIST OF WARNINGS IN ALL ENDOSSEOUS DENTAL IMPLANT LABELING. THE SPECIFIC CAUSE FOR A PARTICULAR COMPLAINT IS OFTEN NOT READILY IDENTIFIED AS THERE ARE VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE. THESE INCLUDE PATIENT FACTORS SUCH AS PRIOR ORAL INFECTION, POOR BONE QUALITY OR QUANTITY, SYSTEMIC CONDITIONS SUCH AS DIABETES AND UNCONTROLLED HYPERTENSION. TECHNIQUE FACTORS SUCH AS OVERHEATING OF THE IMPLANT SITE MAY CAUSE NECROSIS OF THE BONE, PREVENTING GROWTH (PELAYO ET AL., 2008; TURKYILMAZ & AL., 2008). PATIENT HABITS SUCH AS TOBACCO USE (HEITZ-MAYFIELD & HUYNH-BA, 2009), ALCOHOL OR DRUG ABUSE, POOR ORAL HYGIENE, AND BRUXISM (SALVI & BRAEGGER, 2009) MAY ALSO LEAD TO IMPLANT FAILURE. IN ADDITION, IMPROPER SURGICAL TECHNIQUE CAN LEAD TO IMPLANT FAILURE AND/OR LOSS OF SUPPORTING BONE (SALVI & BRAEGGER, 2009). ADDITIONAL HEALTH EFFECT CLINICAL CODE-3626, CANCER/CANCER TREATMENT.
KEYSTONE DENTAL INC. PROVIDES LABELING WITH ALL IMPLANTS. FAILURE TO OSSEOINTEGRATE AND LOSS OF OSSEOINTEGRATION (IMPLANT MOBILITY) IS IDENTIFIED AS AN ADVERSE REACTION AND IDENTIFIED IN THE LIST OF WARNINGS IN ALL ENDOSSEOUS DENTAL IMPLANT LABELING. THE SPECIFIC CAUSE FOR A PARTICULAR COMPLAINT IS OFTEN NOT READILY IDENTIFIED AS THERE ARE VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE. THESE INCLUDE PATIENT FACTORS SUCH AS PRIOR ORAL INFECTION, POOR BONE QUALITY OR QUANTITY, SYSTEMIC CONDITIONS SUCH AS DIABETES AND UNCONTROLLED HYPERTENSION. TECHNIQUE FACTORS SUCH AS OVERHEATING OF THE IMPLANT SITE MAY CAUSE NECROSIS OF THE BONE, PREVENTING GROWTH (PELAYO ET AL., 2008; TURKYILMAZ & AL., 2008). PATIENT HABITS SUCH AS TOBACCO USE (HEITZ-MAYFIELD & HUYNH-BA, 2009), ALCOHOL OR DRUG ABUSE, POOR ORAL HYGIENE, AND BRUXISM (SALVI & BRAEGGER, 2009) MAY ALSO LEAD TO IMPLANT FAILURE. IN ADDITION, IMPROPER SURGICAL TECHNIQUE CAN LEAD TO IMPLANT FAILURE AND/OR LOSS OF SUPPORTING BONE (SALVI & BRAEGGER, 2009). ADDITIONAL HEALTH EFFECT CLINICAL CODE-3626, CANCER/CANCER TREATMENT
FAILED TO OSSEOINTEGRATE.
FAILED TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421949 | DYMIC | DYNAMIC IMPLANT SP 4.2X13 | DZE | KEYSTONE DENTAL, INC. | 21-70009 | WO-023745 | D76821700090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Female | Required Intervention |