SP, Ø4.8MM WN, SLA 10MM Adverse Event — Injury (MDR 0009613348-2020-24722)
SP, Ø4.8MM WN, SLA 10MM Adverse Event — Injury (MDR 0009613348-2020-24722) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SP, Ø4.8MM WN, SLA 10MM; Generic name: ENDOSSEOUS DENTAL IMPLANT; Manufacturer: INSTITUT STRAUMANN AG.
| Device | SP, Ø4.8MM WN, SLA 10MM |
|---|---|
| Generic name | ENDOSSEOUS DENTAL IMPLANT |
| Manufacturer | INSTITUT STRAUMANN AG |
| Report number | 0009613348-2020-24722 |
| 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 LOSS OF AN ENDOSSEOUS DENTAL IMPLANT AFTER SUCCESSFUL OSSEOINTEGRATION AND RESTORATION IS A KNOWN INHERENT RISK OF THE PROCEDURE. IMPLANTS MAY HAVE TO BE REMOVED IN CASE ONE OR MORE |
| Source | openFDA MAUDE (device adverse events) |
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