MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-11-20 for FFS IMPLANTS UNK manufactured by Orthofix Srl.
[4110689]
The information provided by the local distributor indicates: (b)(6). Event description: on insertion of the bd, sudden breakage at transition between thread and rest of bd. Event notified by the hospital involved to the (b)(6) competent authority ((b)(6)). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11320272]
Analysis of historical records: the device involved in this event has not yet been received by orthofix srl. Unfortunately also the device code and batch number have not been made available and therefore it was not possible to perform the verification of the historical data. Technical evaluation: the device involved in this event has not yet been received by orthofix sr. The technical evaluation will be performed as soon as the device becomes available. Manufacturer comments: orthofix srl has requested further information on the event, by sending an official letter to the surgeon involved, such as code and batch number of the device involved; patient diagnosis; surgery description; body part to which device was applied; patient information (age, sex, weight and height); information on patient adverse effects, if any; copies of the operative report and copies of the pre and post-operative x-rays; information on patient current health condition and device availability for the technical evaluation. As soon as further information will be available, orthofix srl will provide you with a follow up report. Orthofix srl continues monitoring the devices on the market.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680825-2013-00034 |
| MDR Report Key | 3514779 |
| Report Source | 01,08 |
| Date Received | 2013-11-20 |
| Date of Report | 2013-11-21 |
| Date of Event | 2013-08-08 |
| Date Mfgr Received | 2013-11-11 |
| Date Added to Maude | 2013-12-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROBERTO DONADELLO, VP |
| Manufacturer Street | VIA DELLE NAZIONI 9 |
| Manufacturer City | BUSSOLENGO,VERONA 37012 |
| Manufacturer Country | IT |
| Manufacturer Postal | 37012 |
| Manufacturer Phone | 9045671900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FFS IMPLANTS |
| Generic Name | FFS IMPLANTS |
| Product Code | JEC |
| Date Received | 2013-11-20 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHOFIX SRL |
| Manufacturer Address | BUSSOLENGO,VERONA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-11-20 |