MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for DURO-JECT VERTEBROPLASTY INJECTOR SET N/A DURO-100 manufactured by Cook Inc.
[77626170]
(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[77626171]
International customer reported that a patient was undergoing a vertebral cementoplasty. The physician reported that the pistolet of the duro-ject vertebroplasty injector set broke during a procedure. The user exerted 'too much pressure" while he was screwing the device to make the cement pass through the tube. A new injector set was obtained and used to complete the procedure. There are no reported adverse patient consequences. The device is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-01404 |
| MDR Report Key | 6636143 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-05-16 |
| Date Mfgr Received | 2017-11-28 |
| Device Manufacturer Date | 2017-01-04 |
| Date Added to Maude | 2017-06-13 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DURO-JECT VERTEBROPLASTY INJECTOR SET |
| Product Code | OAR |
| Date Received | 2017-06-13 |
| Model Number | N/A |
| Catalog Number | DURO-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-13 |