MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-11-08 for CERTAIN? LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) ILPC443U manufactured by Biomet 3i.
Report Number | 0001038806-2019-01335 |
MDR Report Key | 9296254 |
Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
Date Received | 2019-11-08 |
Date of Report | 2019-11-08 |
Date of Event | 2019-09-21 |
Date Mfgr Received | 2019-10-11 |
Date Added to Maude | 2019-11-08 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS SUSANNE TAYLOR |
Manufacturer Street | 4555 RIVERSIDE DRIVE |
Manufacturer City | PALM BEACH GARDENS FL 33410 |
Manufacturer Country | US |
Manufacturer Postal | 33410 |
Manufacturer Phone | 5617766700 |
Manufacturer G1 | BIOMET 3I |
Manufacturer Street | 4555 RIVERSIDE DRIVE |
Manufacturer City | PALM BEACH GARDENS FL 33410 |
Manufacturer Country | US |
Manufacturer Postal Code | 33410 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CERTAIN? LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) |
Generic Name | ABUTMENT |
Product Code | NHA |
Date Received | 2019-11-08 |
Returned To Mfg | 2019-10-11 |
Catalog Number | ILPC443U |
Lot Number | 2018080254 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BIOMET 3I |
Manufacturer Address | 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US 33410 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-08 |