FDA Adverse Event
Malfunction
Summary report: N
SCREWINDIRECT IMPLANT
MDR report key: 11700140
·
Received April 21, 2021
Report
- Report Number
- 3001617766-2021-02268
- Event Type
- Malfunction
- Date Received
- April 21, 2021
- Date of Event
- December 3, 2020
- Report Date
- April 21, 2021
- Manufacturer
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Product Code
- DZE
- UDI-DI
- 10841307104810
- PMA / PMN Number
- K061319
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
PATIENT'S WEIGHT WAS NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED LOSS OF IMPLANT TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 597876 | SCREWINDIRECT IMPLANT | DENTAL IMPLANT | DZE | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NA | 140490 | 10841307104810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR |