InjuryDEZ
SEVEN XD INT. HEX. IMPLANT D3.75 L8MM SP
Received Feb 4, 2025
Report 3004203816-2025-06073 · MDR key 21305016
Device
Generic name
Igm, Rhodamine, Antigen, Antiserum, Control
Manufacturer
Mis Implants Technologies Ltd.Model number
N/ACatalog number
MF7-D08375
Lot number
W22014690
Product problems
- Failure to Osseointegrate
- Failure to Osseointegrate
Patient
46 YR · Female
- Failure of Implant
- Failure of Implant
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.