InjuryDEZ
SEVEN XD INT. HEX. IMPLANT D4.2 L8MM, SP
Received Sep 15, 2025
Report 3004203816-2025-36824 · MDR key 23057268
Device
Generic name
Igm, Rhodamine, Antigen, Antiserum, Control
Manufacturer
Mis Implants Technologies Ltd.Catalog number
MF7-D08420
Lot number
W24000350
Product problems
- Failure to Osseointegrate
- Failure to Osseointegrate
Patient
NA · Female
- Failure of Implant
- Failure of Implant
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Additional Manufacturer Narrative
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.