ADVN+
Report
- Report Number
- 3009161350-2025-94815
- Event Type
- Injury
- Date Received
- September 21, 2025
- Date of Event
- July 31, 2025
- Report Date
- September 21, 2025
- Manufacturer
- PALTOP ADVANCED DENTAL SOLUTIONS INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN AND INHERENT RISK OF DENTAL IMPLANTS AND IS DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEMS1, 2 (SEE E.G., KELLER, 1995; BORNSTEIN, 2008,).PALTOP DENTAL SOLUTIONS INC. PROVIDES IFU 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 END-OSSEOUS DENTAL IMPLANT LABELLING. 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 SYSTEMIC MEDICAL CONDITION (UNCONTROLLED DIABETES MELLITUS, AIDS, OSTEOPOROSIS), POOR BONE QUALITY AND QUANTITY OF BONE IN WHICH THE IMPLANT IS IMPLANTED, MEDICATIONS (CORTICOSTEROIDS, BISPHOSPHONATES), HARMFUL HABITS TO HEALING (SMOKING), SECONDARY INFECTION AND/OR SURGICAL TRAUMA, UNEXPERIENCED CLINICIAN, IMPROPER SURGICAL TECHNIQUE, OR MOBILITY OF THE IMPLANT LEADS TO ITS REMOVAL OR REPLACEMENT, HENCE DENTAL IMPLANT FAILURE. IN ADDITION, A RATE OF IMPLANT FAILURE THAT DOES NOT AFFECT THE PRODUCTS' RISK ASSESSMENT DOES NOT REQUIRE INVESTIGATION AS IT IS A WELL-KNOWN FAILURE MODE WHICH HAS BEEN ADEQUATELY STUDIED IN THE PAST.
FAILURE TO OSSEOINTEGRATE IS A WELL-KNOWN AND INHERENT RISK OF DENTAL IMPLANTS AND IS DOCUMENTED IN THE LITERATURE ACROSS IMPLANT SYSTEMS1, 2 (SEE E.G., KELLER, 1995; BORNSTEIN, 2008,).PALTOP DENTAL SOLUTIONS INC. PROVIDES IFU 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 END-OSSEOUS DENTAL IMPLANT LABELLING. 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 SYSTEMIC MEDICAL CONDITION (UNCONTROLLED DIABETES MELLITUS, AIDS, OSTEOPOROSIS), POOR BONE QUALITY AND QUANTITY OF BONE IN WHICH THE IMPLANT IS IMPLANTED, MEDICATIONS (CORTICOSTEROIDS, BISPHOSPHONATES), HARMFUL HABITS TO HEALING (SMOKING), SECONDARY INFECTION AND/OR SURGICAL TRAUMA, UNEXPERIENCED CLINICIAN, IMPROPER SURGICAL TECHNIQUE, OR MOBILITY OF THE IMPLANT LEADS TO ITS REMOVAL OR REPLACEMENT, HENCE DENTAL IMPLANT FAILURE. IN ADDITION, A RATE OF IMPLANT FAILURE THAT DOES NOT AFFECT THE PRODUCTS' RISK ASSESSMENT DOES NOT REQUIRE INVESTIGATION AS IT IS A WELL-KNOWN FAILURE MODE WHICH HAS BEEN ADEQUATELY STUDIED IN THE PAST.
FAILED TO OSSEOINTEGRATE.
FAILED TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1822429 | ADVN+ | ADVANCED PLUS IMPLANT SP 5X10 | DZE | PALTOP ADVANCED DENTAL SOLUTIONS INC. | 20-70013P | WO-015519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |