MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-18 for IMPLANT INSERTER SH CONNECTION TFT30101 manufactured by Eit Emerging Implant Technologies Gmbh.
| Report Number | 3013730328-2020-00014 |
| MDR Report Key | 9847481 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-18 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | EIT EMERGING IMPLANT TECHNOLOGIES GMBH |
| Manufacturer Street | EISENBAHNSTRASSE 84 |
| Manufacturer City | WURMLINGEN D-78573 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-78573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANT INSERTER SH CONNECTION |
| Generic Name | INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-03-02 |
| Model Number | TFT30101 |
| Catalog Number | TFT30101 |
| Lot Number | E18DI0865 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EIT EMERGING IMPLANT TECHNOLOGIES GMBH |
| Manufacturer Address | EISENBAHNSTRASSE 84 WURMLINGEN D-78573 D-78573 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |