MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-31 for BLT ?2.9MM SC, SLACTIVE? 12MM, RXD, LOXI 021.0012 manufactured by Institut Straumann Ag.
[115545694]
The batch number could be verified. Our manufacturing q-system assures, that production and process controls are in place to ensure that batches confirm to the applicable specifications before they are distributed. The non-integration of an endosseous dental implant during the healing phase is a known inherent risk of the treatment with dental implants. Most implant failures occur before occlusal loading (analainen et al. 2013, koldsland et al. 2009). Based on clinical studies about 1-3% of the implants fail within the first year after implantation (ganeles et al. 2008). Implants may have to be removed in case one or more of the implant success criteria are not met. Implant success criteria according to buser et al. (1991) are: 1. Absence of persistent subjective complaints such as pain, foreign body sensation and/or disesthesia. 2. Absence of a recurrent peri-implant infection with suppuration. 3. Absence of implant mobility. 4. Absence of a continuous radiolucency around the implant. The manufacturer's trend analysis confirms that the reported early failure rate associated with its dental implants is below the expected failure rate for this treatment as published in the scientific literature.
Patient Sequence No: 1, Text Type: N, H10
[115545695]
The clinician reported that 5 months after the dental implant was placed in fdi site #13 of the patient's mouth, the implant was removed. It was reported that type ii bone quality, good hygiene around the implant, and implant mobility at the time of the event. The product was returned to the manufacturer for investigation. There were no reported post-operative complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222315-2018-00430 |
| MDR Report Key | 7734907 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-06-25 |
| Date Mfgr Received | 2018-07-13 |
| Date Added to Maude | 2018-07-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNIFER JACKSON |
| Manufacturer Street | 60 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer G1 | INSTITUT STRAUMANN AG |
| Manufacturer Street | PETER-MERIAN-WEG 12 |
| Manufacturer City | BASEL, CH-4002 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH-4002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLT ?2.9MM SC, SLACTIVE? 12MM, RXD, LOXI |
| Generic Name | ENDESSEOUS DENTAL IMPLANGT |
| Product Code | ODU |
| Date Received | 2018-07-31 |
| Returned To Mfg | 2018-07-13 |
| Model Number | NA |
| Catalog Number | 021.0012 |
| Lot Number | NJ296 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INSTITUT STRAUMANN AG |
| Manufacturer Address | PETER-MERIAN-WEG 12 BASEL, CH-4002 SZ CH-4002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-31 |