MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-14 for PIEZOSURGERY MT1S-10 03600007 manufactured by Mectron S.p.a..
[130357080]
During a strip craniectomy for the release of the sagittal suture, the medical insert tip broke while in use. It was reported that the patient required re-opening of the incision and additional anesthesia to remove the object. The object was removed without any reported complication. No further information was received regarding the patient status. The event was reported to have occurred in (b)(6) 2018, but the exact date was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005282635-2018-00002 |
| MDR Report Key | 8164921 |
| Date Received | 2018-12-14 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-04-01 |
| Date Facility Aware | 2018-11-26 |
| Report Date | 2018-12-10 |
| Date Reported to Mfgr | 2018-12-10 |
| Date Added to Maude | 2018-12-14 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PIEZOSURGERY |
| Generic Name | PIEZOSURGERY MEDICAL INSERT TIP |
| Product Code | JDX |
| Date Received | 2018-12-14 |
| Model Number | MT1S-10 |
| Catalog Number | 03600007 |
| Lot Number | 18000236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MECTRON S.P.A. |
| Manufacturer Address | VIA LORETO 15A CARASCO, GE 16042 IT 16042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-14 |