SP Ø 4.8MM RN, SLACTIVE® 8MM, TIZR, NTP Adverse Event — Injury (MDR 0009613348-2020-24719)
SP Ø 4.8MM RN, SLACTIVE® 8MM, TIZR, NTP Adverse Event — Injury (MDR 0009613348-2020-24719) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SP Ø 4.8MM RN, SLACTIVE® 8MM, TIZR, NTP; Generic name: ENDOSSEOUS DENTAL IMPLANT; Manufacturer: INSTITUT STRAUMANN AG.
| Device | SP Ø 4.8MM RN, SLACTIVE® 8MM, TIZR, NTP |
|---|---|
| Generic name | ENDOSSEOUS DENTAL IMPLANT |
| Manufacturer | INSTITUT STRAUMANN AG |
| Report number | 0009613348-2020-24719 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | FOREIGN, HEALTH PROFESSIONAL |
| Narrative | THE BATCH NUMBER COULD NOT BE VERIFIED DUE TO INCOMPLETE OR MISSING INFORMATION AND / OR PRODUCT FROM THE CUSTOMER. 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 T |
| Source | openFDA MAUDE (device adverse events) |
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