ZYGOMATIC IMPLANT
Report
- Report Number
- 3011390931-2024-00357
- Event Type
- Injury
- Date Received
- June 25, 2024
- Date of Event
- September 15, 2023
- Report Date
- June 25, 2024
- Manufacturer
- NORIS MEDICAL LTD
- Product Code
- DZE
- UDI-DI
- 07290108812336
- PMA / PMN Number
- K151909
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THE DHR WAS REVIEWED FOR LOT#0024044 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE INVESTIGATION FOR THIS EVENT HAS NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. OUR MANUFACTURING SYSTEM ASSURES, THAT PRODUCTION AND PROCESS CONTROLS ARE IN PLACE TO ENSURE THAT BATCHES CONFORM TO THE APPLICABLE SPECIFICATIONS BEFORE THEY ARE DISTRIBUTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.
UDI RELATED DATA QUALITY UPDATES ONLY.
A HEALTHCARE PROFESSIONAL REPORTED THAT A NM-F4440 LOT#0024044 IMPLANT LACKED PRIMARY STABILITY. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 284473 | ZYGOMATIC IMPLANT | ZYGOMATIC DENTAL IMPLANT | DZE | NORIS MEDICAL LTD | NM-F4440 | 0024044 | 07290108812336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Unknown |