MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-02 for OSTEO-FORCE VERTEBROPLASTY INJECTOR SET HPIS-100 manufactured by Cook Inc.
[74409274]
(b)(4). The event is currently under investigation. A follow-up report will be sent upon conclusion.
Patient Sequence No: 1, Text Type: N, H10
[74409275]
It was reported that during a lumbar vertebroplasty the osteo-force vertebroplasty injector device fractured during use. A second device was used and also broke. The medical team was able to disengage the plunger and manually push the cement out and a third device was used to completed the procedure. There was no reported injury to the patient. The device has been returned to the manufacturer for evaluation. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-00907 |
| MDR Report Key | 6536851 |
| Date Received | 2017-05-02 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-04-14 |
| Date Mfgr Received | 2017-08-16 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-05-02 |
| 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 | OSTEO-FORCE VERTEBROPLASTY INJECTOR SET |
| Product Code | OAR |
| Date Received | 2017-05-02 |
| Catalog Number | HPIS-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 | 2017-05-02 |