MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-02-11 for PIEZOSURGERY PIEZOSURGERY 3 05120035 manufactured by Mectron S.p.a..
[135739685]
Manufacturer received: (b)(4) 3 , sn (b)(4), device object of this communication, and related handpieces and inserts on march 29, 2018 for investigation purposes. (b)(4) 3 manufactured on 03/30/2014 was found to work appropriately as well as the handpiece s. N. (b)(4). All functional parameters resulted correct while the handpiece s. N. (b)(4) was broken. The inserts, that are the components that come into direct contact to the patient, to a careful analysis resulted all worn and bended in disagree with stated by the manufacturer at section 10. 1 "important safety information regarding the inserts" of the user manual. Even the diamonds inserts, which, as is clearly stated in the user manual of the device, section 06. 6 inserts are single use, have wear level that suggests a repeated use that is not compatible with the statements the manufacturer included into the ifu. Moreover their production and in-process and final controls documents related to (b)(4) 3 and related inserts did not show any anomaly.
Patient Sequence No: 1, Text Type: N, H10
[135739686]
It was reported by the distributor (b)(4) on feb. 27, 2018 that a doctor had a patient who returned for a post operation check up on (b)(6) 2018 and was discovered to have slow post-operative healing and necrotic bone tissue on the lingual ridge. Per the distributor (b)(4), additional treatment was performed to treat the bone necrosis on (b)(6), (b)(6), and (b)(6) to remove necrotic bone on the lingual ridge. The original treatment was for an extraction. The original treatment date is unknown; however, it was mentioned that the original surgery occured three (3) reported multiple other cases of this nature, but no additional details where provided regarding those patients. Additional medwatch reports will be filled if information becomes available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003933619-2018-00001 |
| MDR Report Key | 8325507 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2019-02-11 |
| Date of Report | 2018-04-26 |
| Date of Event | 2018-02-06 |
| Device Manufacturer Date | 2014-03-30 |
| Date Added to Maude | 2019-02-11 |
| 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 |
| Reporter Occupation | DENTIST |
| 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 | 3 |
| Brand Name | PIEZOSURGERY |
| Generic Name | PIEZOSURGERY 3 |
| Product Code | DZI |
| Date Received | 2019-02-11 |
| Returned To Mfg | 2018-03-29 |
| Model Number | PIEZOSURGERY 3 |
| Catalog Number | 05120035 |
| 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 | 1. Required No Informationntervention | 2019-02-11 |