FDA Adverse Event
Malfunction
Summary report: N
CONICAL ABUTMENT GOLD STANDARD ZR TM 4.1MM (D) X 2MM (H)
MDR report key: 5820157
·
Received July 25, 2016
Report
- Report Number
- 0001038806-2016-00192
- Event Type
- Malfunction
- Date Received
- July 25, 2016
- Date of Event
- June 28, 2016
- Report Date
- July 1, 2016
- Manufacturer
- BIOMET 3I
- Product Code
- NHA
- PMA / PMN Number
- PK072642
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
VISUAL INSPECTION HAS CONFIRMED THE REPORTED EVENT. THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT PROVIDE ANY INDICATION OF MANUFACTURING DEVIATION THAT WOULD CONTRIBUTE TO THIS EVENT. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED. UDI: (B)(4).
Description of Event or Problem · 1
THE DENTIST REPORTED THE ABUTMENT SCREW FRACTURED. THE IMPLANT REMAINS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473589 | CONICAL ABUTMENT GOLD STANDARD ZR TM 4.1MM (D) X 2MM (H) | ABUTMENT | NHA | BIOMET 3I | 930257 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |