FDA Adverse Event
Malfunction
Summary report: N
IMP,TSV,4.7,11.5,MTX,MG
MDR report key: 7544483
·
Received May 25, 2018
Report
- Report Number
- 0001038806-2018-00578
- Event Type
- Malfunction
- Date Received
- May 25, 2018
- Date of Event
- April 2, 2018
- Report Date
- September 24, 2018
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- PK101977
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINATE THAT INFORMATION WAS PREVIOUSLY SUBMITTED UNDER THE INCORRECT MFR. THIS EVENT WILL BE REPORTED ON MDR-0002023141-2018-00808.
Additional Manufacturer Narrative · 1
(B)(4). PATIENT ID WAS NOT PROVIDED. PATIENT WEIGHT WAS NOT PROVIDED. PRODUCT HAS NOT BEEN RETURNED. ADDITIONAL 510K CODES: K101880.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTERNAL HEX OF THE IMPLANT MOUNT SHEARED OFF IN THE IMPLANT WHEN PLACING IT. THE CLINICIAN WAS ABLE TO RETRIEVE THE BROKEN PORTION BUT THE INTERNAL THREADS OF THE IMPLANT ARE DAMAGED. TOOTH LOCATION # 20 PATIENT WILL RETURN FOR REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387462 | IMP,TSV,4.7,11.5,MTX,MG | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 63202155 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |