FDA Adverse Event
Malfunction
Summary report: N
IMP,TSV,4.7,10,MTX,MG
MDR report key: 8121980
·
Received December 1, 2018
Report
- Report Number
- 0001038806-2018-00994
- Event Type
- Malfunction
- Date Received
- December 1, 2018
- Report Date
- December 4, 2018
- Manufacturer
- BIOMET 3I
- Product Code
- DZE
- PMA / PMN Number
- K101977
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
IT WAS DETERMINED THAT INFORMATION WAS PREVIOUSLY SUBMITTED UNDER THE INCORRECT MFR NUMBER. THERE WILL BE NO FURTHER SUPPLEMENTAL REPORTS SUBMITTED UNDER THIS NUMBER. THIS EVENT WILL BE REPORTED ON 0002023141-2018-00939.
Description of Event or Problem · 0
NO FURTHER INFORMATION WILL BE SUBMITTED FOR THIS EVENT.
Additional Manufacturer Narrative · 1
ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT WAS NOT PROVIDED. ETHNICITY NO PROVIDED. DEVICE LOT # WAS NOT PROVIDED/UNKNOWN. PRODUCT HAS NOT BEEN RETURNED. PRODUCT WAS USED. EVENT DATE UNKNOWN. ADDITIONAL 510K CODES: K101880.
Description of Event or Problem · 1
IT WAS REPORTED THAT INTERNAL THREAD WERE DAMAGED. DENTIST RETHREAD THE IMPLANT AND PLACED AN HEALING ABUTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 962144 | IMP,TSV,4.7,10,MTX,MG | DENTAL IMPLANT | DZE | BIOMET 3I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |