MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for PIEZOSURGERY MT1-10 03600001 manufactured by Mectron S.p.a..
[139069605]
The manufacturer mectron s. P. A. Received the insert involved in the event. An investigation was carry out by the manufacturer: the insert returned, mt1-10, lot. Number 18002205, was analysed by an external laboratory. The result of this analysis didn't reveal any critical problem on the structure of the insert. Moreover the design, production, in-process and final controls documents, related to the insert mt1-10, lot 18002205 didn't show any anomaly.
Patient Sequence No: 1, Text Type: N, H10
[139069606]
During the use in a maxillofacial surgery, the insert mt1-10, lot n. 18002205, expiration date 30 july 2023, eto sterilization batch (b)(4), broke. No adverse event occurred to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003933619-2018-00009 |
| MDR Report Key | 8353131 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-01-09 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-10-22 |
| Device Manufacturer Date | 2018-07-30 |
| Date Added to Maude | 2019-02-20 |
| 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. GIOVANNA ROMEO |
| Manufacturer Street | VIAA LORETO 15/A / |
| Manufacturer City | CARASCO, GENOA 16042 |
| Manufacturer Country | IT |
| Manufacturer Postal | 16042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PIEZOSURGERY |
| Generic Name | MT1-10, INSERT FOR GENERAL BONE SURGERY |
| Product Code | JDX |
| Date Received | 2019-02-20 |
| Returned To Mfg | 2018-11-12 |
| Model Number | MT1-10 |
| Catalog Number | 03600001 |
| Lot Number | 18002205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTRON S.P.A. |
| Manufacturer Address | VIA LORETO 15/A / CARASCO, GENOA 16042 IT 16042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |