N
Patient 1
(B)(4). MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
MAUDE MDR 8320243
- MDR report key
- 8320243
- Report number
- 9610612-2019-00055
- Event key
- 0
- Event type
- 3
- Date received
- 2019-02-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. NICOLE BROYLES
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Phone
- 314-314-3145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ROOT ELEVATOR STR.3.0MM #4S | DENTAL | AESCULAP AG | EMJ | DL362R | DL362R | 4500590943 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-08 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN INTRAOPERATIVE ISSUE WITH THE ROOT ELEVATOR. DURING AN UNSPECIFIED PROCEDURE, THE TIP BROKE OFF THE DENTAL INSTRUMENT DURING LEVER EXTRACTION. THE TIP WAS SECURED EASILY WITHOUT ANY INTERVENTION. IT WAS NOTED THAT THE MALFUNCTION OCCURRED DESPITE PROPER HANDLING AND STERILIZATION PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.