MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-11 for CONFIDENCE KIT, NO NEEDLES 283913000 manufactured by Depuy Spine Inc.
[184164277]
If the information is unknown, not available or does not apply, the section/field of the form is left blank. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[184164278]
It was reported that (b)(6) 2020, during spinal fusion surgery, the surgeon was using confidence cement with viper fenestrated screws. The pump in the kit lost pressure and came apart. There was a surgical delay of five (5) minutes. There were no fragments generated. Patient status is unknown. The procedure was successfully completed. Concomitant device reported: unknown viper fenestrated screws (part#: unknown, lot#: unknown, quantity: unknown). This report is for one (1) confidence kit, no needles. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2020-00685 |
| MDR Report Key | 9817782 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONFIDENCE KIT, NO NEEDLES |
| Generic Name | CEMENT, BONE, VERTEBROPLASTY |
| Product Code | NDN |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 283913000 |
| Catalog Number | 283913000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |