MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for BLX SLA ACTIVE/BL SLA ACTIVE/BLT SL /BL SLA - IMPLANTS BLX/BLT/BL manufactured by Straumann Manufacturing Inc..
[184270476]
Ai2o3 particles on titanium dental implant systems following sandblasting and acid-etching process https://www. Hindawi. Com/journals/ijbm/2019/6318429/ i demand what straumann withdraw / recall of blx/bl/blt/sla active/sla implants. Straumann advertises implants as 100% ai-free. Ai in bone and tissues oxidized to ai2o3 therefore, ai2o3 particles in implant surface are more dangerous than even implants alloy with ai contain. Clinicians should be able to expect a clean implant surface when treating their pts. Fda safety report id (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093817 |
| MDR Report Key | 9848064 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-06-02 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLX SLA ACTIVE/BL SLA ACTIVE/BLT SL /BL SLA - IMPLANTS |
| Generic Name | ENDOSSEOUS DENTAL IMPLANT |
| Product Code | NHA |
| Date Received | 2020-03-17 |
| Model Number | BLX/BLT/BL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRAUMANN MANUFACTURING INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |