MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-05 for OSSEOFLEX SN+ OF-0021 manufactured by Osseon Llc.
[61492566]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[61492567]
During the vertebral augmentation procedure, the device was left in the patient for approximately 15 minutes after the cement was injected. The delay caused the cement to harden and a portion of the distal needle broke off (less than 40mm) and remained in the patient as the needle could not be dislodged. No image was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111981-2016-00002 |
| MDR Report Key | 6146522 |
| Date Received | 2016-12-05 |
| Date of Report | 2016-12-05 |
| Date of Event | 2016-11-11 |
| Date Mfgr Received | 2016-11-11 |
| Device Manufacturer Date | 2015-09-24 |
| Date Added to Maude | 2016-12-05 |
| 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. RON CLOUGH |
| Manufacturer Street | 2301 CIRCADIAN WAY SUITE 300 |
| Manufacturer City | SANTA ROSA CA 95407 |
| Manufacturer Country | US |
| Manufacturer Postal | 95407 |
| Manufacturer Phone | 7076365940 |
| Manufacturer G1 | OSSEON LLC |
| Manufacturer Street | 2301 CIRCADIAN WAY SUITE 300 |
| Manufacturer City | SANTA ROSA CA 95407 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95407 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OSSEOFLEX SN+ |
| Generic Name | STEERABLE VERTEBRAL NEEDLE |
| Product Code | OAR |
| Date Received | 2016-12-05 |
| Model Number | OF-0021 |
| Lot Number | 081015-01 |
| Device Expiration Date | 2017-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSEON LLC |
| Manufacturer Address | 2301 CIRCADIAN WAY SUITE 300 SANTA ROSA CA 95407 US 95407 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-12-05 |