FDA Adverse Event
Injury
Summary report: N
LEGACY 3 IMPLANT
MDR report key: 12083805
·
Received June 29, 2021
Report
- Report Number
- 3001617766-2021-03807
- Event Type
- Injury
- Date Received
- June 29, 2021
- Date of Event
- May 28, 2021
- Report Date
- August 25, 2021
- Manufacturer
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Product Code
- DZE
- UDI-DI
- 10841307102250
- PMA / PMN Number
- K090234
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
RE-EVALUATION FOR REPORTABILITY CONCLUDES THAT THIS EVENT IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN HEALTH. THEREFORE, THIS COMPLAINT IS NON-REPORTABLE TO THE FDA. UPDATED SECTION B4 FOR REPORT SUBMISSION DATE, G1 FOR FOLLOW-UP REPORT SUBMITTER, G3 FOR AWARENESS DATE AND G6 FOR REPORT TYPE AND FOLLOW-UP NUMBER. UPDATED H2 FOR FOLLOW-UP TYPE. (B)(4).
Additional Manufacturer Narrative · 1
PATIENT WEIGHT, IMPLANTED AND EXPLANTED DATES ARE UNKNOWN. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. IF THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
PER COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, ERROR IN SURGICAL PROTOCOL WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 980787 | LEGACY 3 IMPLANT | DENTAL IMPLANT | DZE | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NA | 175101 | 10841307102250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |