FDA Adverse Event
Malfunction
Summary report: N
LEGACY 2 IMPLANT
MDR report key: 11937236
·
Received June 4, 2021
Report
- Report Number
- 3001617766-2021-03353
- Event Type
- Malfunction
- Date Received
- June 4, 2021
- Date of Event
- May 1, 2021
- Report Date
- June 16, 2021
- Manufacturer
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Product Code
- DZE
- UDI-DI
- 10841307101260
- PMA / PMN Number
- K192221
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
FOLLOW-UP SUBMITTED TO INDICATE THIS COMPLAINT IS DUPLICATE AND WAS SUBMITTED IN ERROR. 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.
Description of Event or Problem · 0
PER COMPLAINT (B)(4) IS A DUPLICATE SUBMISSION OF COMPLAINT (B)(4).
Additional Manufacturer Narrative · 1
PATIENT IDENTIFIER, AGE, IMPLANT DATE AND EXPLANT DATE WERE NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. PATIENT WEIGHT IS 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 COMPLAINT (B)(4), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 837268 | LEGACY 2 IMPLANT | DENTAL IMPLANT | DZE | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NA | 181014 | 10841307101260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |