FDA Adverse Event
Malfunction
Summary report: N
SIMPLY INTERACTIVE IMPLANT
MDR report key: 12024352
·
Received June 18, 2021
Report
- Report Number
- 3001617766-2021-03663
- Event Type
- Malfunction
- Date Received
- June 18, 2021
- Date of Event
- June 3, 2021
- Report Date
- July 21, 2021
- Manufacturer
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Product Code
- DZE
- UDI-DI
- 10841307106937
- PMA / PMN Number
- K130572
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 0
FOLLOW-UP SUBMITTED TO REPORT DEVICE EVALUATION. DEVICE RECEIVED IS DIFFERENT FROM THE PART THAT WAS INDICATED ON THE INITIAL 3500A REPORT. LOT NUMBER AND MANUFACTURE/EXPIRATION DATES PREVIOUSLY SUBMITTED DO NOT APPLY. LOT NUMBER INFORMATION IS UNKNOWN.
Additional Manufacturer Narrative · 1
PATIENT'S IDENTIFIER WAS NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. PATIENT WEIGHT IS UNKNOWN LOT INFORMATION IS UNKNOWN. IF ADDITIONAL 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), DURING CLINICAL PROCEDURE, COMPONENTS COULD NOT BE SEPARATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 919190 | SIMPLY INTERACTIVE IMPLANT | DENTAL IMPLANT | DZE | IMPLANT DIRECT SYBRON MANUFACTURING LLC | NA | NI | 10841307106937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |