FDA Adverse Event Injury Summary report: N

VEGA RV Ø4.5 X 08MM / VEGA RV Ø4.0 X 08 MM IMPLANT

MDR report key: 22284569 · Received June 18, 2025

Report

Report Number: 3003267134-2025-00001
Event Type: Injury
Date Received: June 18, 2025
Date of Event: December 9, 2019
Report Date: June 17, 2025
Manufacturer: SOADCO, S.L.
Product Code: DZE
PMA / PMN Number: K153098
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

SOADCO, S.L. REQUESTED MORE INFORMATION TO ANALYZE THE INCIDENT, BUT THE CLIENT DID NOT SEND THE AFFECTED DEVICES OR ANY FOLLOW-UP X RAYS FROM THE TIME THE IMPLANTS WERE PLACED OR FROM MOMENTS PRIOR TO EXTRACTION. BASED ON THE AVAILABLE INFORMATION, IT CAN BE STATED THAT THE INCIDENCE IS MORE RELATED TO THE PAOTIENT'S ORAL HEALTH THAN TO AN INCIDENCE OF THE PRODUCT TO AN INCIDENCE OF THE PRODUCT. IT IS OBSERVED THAT THE PATIENT IS A SMOKER, A HABIT CONTRAINDICATED.

Description of Event or Problem · 0

A DISTRIBUTOR (KLOCKNER OF NORTH AMERICA) INFORMS SOADCO, S.L. THAT A DOCTOR COMMENTS THAT: -THE PATIENT PRESENTED SEVERE PERI-IMPLANTITIS 3 WEEKS AFTER THE SURGICAL OPERATION AND A MODERATE RESORPTION OF THE ALVEOLAR CREST IS OBSERVED, WITH BONE TYPE I-II. THE USER SPECIFIES IN THE QUALITY REPORT SEND TO THE MANUFACTURER (SOADCO, S.L.) THAT THE FAILURE IS DUE TO SOME PATIENT'S UNKNOWN FACTORS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
748240	VEGA RV Ø4.5 X 08MM / VEGA RV Ø4.0 X 08 MM IMPLANT	DENTAL IMPLANT	DZE	SOADCO, S.L.	18 45 08 / 18 40 08	20652-1061 / 20650-1061

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR	Male	Required Intervention