FDA Adverse Event
Injury
Summary report: N
LEGACY 3 IMPLANT
MDR report key: 9150476
·
Received October 3, 2019
Report
- Report Number
- 3001617766-2019-04293
- Event Type
- Injury
- Date Received
- October 3, 2019
- Date of Event
- February 19, 2019
- Report Date
- October 21, 2019
- Manufacturer
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Product Code
- DZE
- UDI-DI
- 10841307102137
- PMA / PMN Number
- K090234
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CS
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION.
Description of Event or Problem · 0
REVIEWED ATTACHED CUSTOMER FEEDBACK FORM: YES. CONTRAINDICATIONS RELEVANT TO FAILURE: DIABETES. PART NUMBER: 854213. REVISION: C. APPEARANCE: IMPLANT RECEIVED IN GOOD USED CONDITION. SPECIFICATION SHOULD BE: LENGTH: .512 ± .003, SPECIFICATION AS FOUND: .5122, DIAMETER: .1638 ± .0005, SPECIFICATION AS FOUND: .1639. COMMENTS: IMPLANT MEETS ALL APPLICABLE SPECIFICATIONS. DATE OF INSPECTION: 10/02/19.
Description of Event or Problem · 1
PER COMPLAINT (B)(4), DURING POST OPERATIVE CHECK, PATIENT EXPERIENCED LOSS OR FAILURE OF IMPLANT TO INTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 944675 | LEGACY 3 IMPLANT | DENTAL IMPLANT | DZE | IMPLANT DIRECT SYBRON MANUFACTURING LLC | 100470 | 10841307102137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |