MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for PIEZOSURGERY MT1S-10 03600007 manufactured by .
[136619096]
Manufacturer mectron (b)(4) didn't receive the insert involved in the event. However the production, in-process and final controls documents, related to the insert mt1s -10, lot n. 18000236, didn't show any anomaly.
Patient Sequence No: 1, Text Type: N, H10
[136619097]
During the use in a strip craniectomy, for release of sagittal suture, the insert mt1s-10 broke. This required an additional procedure to remove the fragment of the insert. Device failed (e. G. Broke, couldn't get it to work or stopped working).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003933619-2018-00005 |
| MDR Report Key | 8350057 |
| Date Received | 2019-02-19 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-12-10 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2019-02-19 |
| 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 | VIA 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 | MT1S - 10, INSERT FOR GENERAL BONE SURGERY |
| Product Code | DZI |
| Date Received | 2019-02-19 |
| Model Number | MT1S-10 |
| Catalog Number | 03600007 |
| Lot Number | 18000236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | VIA LORETO 15/A CARASCO, GENOA 16042 IT 16042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |