MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for ROOT ELEVATOR STR.3.0MM #4S DL362R manufactured by Aesculap Ag.
[136122477]
(b)(4). Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
Patient Sequence No: 1, Text Type: N, H10
[136122478]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00055 |
| MDR Report Key | 8320243 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-12 |
| Date Facility Aware | 2019-02-12 |
| Date Mfgr Received | 2019-02-08 |
| Device Manufacturer Date | 2006-05-22 |
| Date Added to Maude | 2019-02-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ROOT ELEVATOR STR.3.0MM #4S |
| Generic Name | DENTAL |
| Product Code | EMJ |
| Date Received | 2019-02-08 |
| Returned To Mfg | 2019-01-23 |
| Model Number | DL362R |
| Catalog Number | DL362R |
| Lot Number | 4500590943 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |