FDA Adverse Event
Malfunction
Summary report: N
LEGACY 3 IMPLANT
MDR report key: 12015737
·
Received June 17, 2021
Report
- Report Number
- 3001617766-2021-03600
- Event Type
- Malfunction
- Date Received
- June 17, 2021
- Report Date
- July 9, 2021
- Manufacturer
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Product Code
- DZE
- UDI-DI
- 10841307102168
- PMA / PMN Number
- K090234
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION. WHEN INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative · 1
PATIENT AGE AND EXPLANT DATE ARE UNKNOWN. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
PER (B)(4), DURING CLINICAL PROCEDURE, BONE FRACTURE WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 917335 | LEGACY 3 IMPLANT | DENTAL IMPLANT | DZE | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NA | 168283 | 10841307102168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |