SP, Ø4.8MM WN, SLA 8MM Adverse Event — Injury (MDR 0009613348-2020-24705)
SP, Ø4.8MM WN, SLA 8MM Adverse Event — Injury (MDR 0009613348-2020-24705) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SP, Ø4.8MM WN, SLA 8MM; Generic name: ENDOSSEOUS DENTAL IMPLANT; Manufacturer: INSTITUT STRAUMANN AG.
| Device | SP, Ø4.8MM WN, SLA 8MM |
|---|---|
| Generic name | ENDOSSEOUS DENTAL IMPLANT |
| Manufacturer | INSTITUT STRAUMANN AG |
| Report number | 0009613348-2020-24705 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | 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 |
| Source | openFDA MAUDE (device adverse events) |
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