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BL, Ø 4.8MM RC, SLACTIVE 12MM, TIZR, NTP Adverse Event — Injury (MDR 0009613348-2020-24714)

BL, Ø 4.8MM RC, SLACTIVE 12MM, TIZR, NTP Adverse Event — Injury (MDR 0009613348-2020-24714) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BL, Ø 4.8MM RC, SLACTIVE 12MM, TIZR, NTP; Generic name: ENDOSSEOUS DENTAL IMPLANT; Manufacturer: INSTITUT STRAUMANN AG.

DeviceBL, Ø 4.8MM RC, SLACTIVE 12MM, TIZR, NTP
Generic nameENDOSSEOUS DENTAL IMPLANT
ManufacturerINSTITUT STRAUMANN AG
Report number0009613348-2020-24714
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceFOREIGN, HEALTH PROFESSIONAL
NarrativeTHE 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 REMOVAL OF A DENTAL IMPLANT DURING SURGERY WITHOUT THE REPLACEMENT OF ANOTHER DENTAL IMPLANT IS A KNOW
SourceopenFDA MAUDE (device adverse events)

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