FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN SCREW
MDR report key: 6873932
·
Received September 18, 2017
Report
- Report Number
- 0001038806-2017-00634
- Event Type
- Malfunction
- Date Received
- September 18, 2017
- Date of Event
- April 10, 2017
- Report Date
- October 18, 2017
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON SEP 19, 2017, REVEALING THAT THE REPORTED ITEM IS ABUTMENT SCREW MHLASP. IT HAS BEEN DETERMINED THAT THE PRIOR SUBMISSION FOR MFR-0001038806-2017-00634, SUBMITTED ON SEP 18, 2017 IS NO LONGER CONSIDERED A REPORTABLE EVENT BY THE MANUFACTURER AND NO FURTHER REPORTS WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
DEVICE HAS NOT YET BEEN RETURNED TO MANUFACTURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT UNKNOWN ABUTMENT SCREW FRACTURED. NOTHING IS WRONG WITH IMPLANT (TSVB10). TOOTH LOCATION #14.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651601 | UNKNOWN SCREW | DZE | ZIMMER DENTAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |