MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-19 for PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM 11-8999 manufactured by Spine Wave, Inc..
| Report Number | 3004638600-2020-00001 |
| MDR Report Key | 9729765 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-19 |
| 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. RONALD SMITH |
| Manufacturer Street | 3 ENTERPRISE DRIVE SUITE 210 |
| Manufacturer City | SHELTON, CT |
| Manufacturer Country | US |
| Manufacturer Phone | 9449494 |
| Manufacturer G1 | SPINE WAVE, INC. |
| Manufacturer Street | 3 ENTERPRISE DRIVE SUITE 210 |
| Manufacturer City | SHELTON, CT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM |
| Generic Name | POSTERIOR CERVICO-THORACIC FIXATION SYSTEM |
| Product Code | NKG |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-01-22 |
| Model Number | 11-8999 |
| Catalog Number | 11-8999 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINE WAVE, INC. |
| Manufacturer Address | 3 ENTERPRISE DRIVE SUITE 210 SHELTON, CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |