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IMP,TSV,4.7,8,MTX,MG Adverse Event — Injury (MDR 0002023141-2020-00817)

IMP,TSV,4.7,8,MTX,MG Adverse Event — Injury (MDR 0002023141-2020-00817) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: IMP,TSV,4.7,8,MTX,MG; Generic name: DENTAL IMPLANT; Manufacturer: ZIMMER DENTAL.

DeviceIMP,TSV,4.7,8,MTX,MG
Generic nameDENTAL IMPLANT
ManufacturerZIMMER DENTAL
Report number0002023141-2020-00817
Event typeInjury
Product problemY
Date received2020-04-27
NarrativeONE TAPERED SCREW-VENT IMPLANT (TSVTWB8) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINOR SIGNS OF WEAR DUE TO USAGE; THE DEVICES WERE IN GOOD CONDITION. FUNCTIONAL TESTING WAS PERFORMED TO DISENGAGE THE MOUNT AND IMPLANT. THE DEVICES WERE ABLE TO DISENGAGE AND ENGAGE SUCCESSFULLY (IMAGE 2). PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERAT
SourceopenFDA MAUDE (device adverse events)

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