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 2019-11-13 for T-HANDLE INSERTER PET30101 manufactured by Eit Emerging Implant Technologies Gmbh.
| Report Number | 3013730328-2019-00047 |
| MDR Report Key | 9316959 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-13 |
| Date of Report | 2019-08-20 |
| Date Mfgr Received | 2019-11-13 |
| Device Manufacturer Date | 2016-09-08 |
| Date Added to Maude | 2019-11-13 |
| 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 | EISENBAHNSTRASSE 84 |
| Manufacturer City | WURMLINGEN D-78573 |
| Manufacturer Postal | D-78573 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | EIT EMERGING IMPLANT TECHNOLOGIES GMBH |
| Manufacturer Street | EISENBAHNSTRASSE 84 |
| Manufacturer City | WURMLINGEN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T-HANDLE INSERTER |
| Generic Name | INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR |
| Product Code | MAX |
| Date Received | 2019-11-13 |
| Catalog Number | PET30101 |
| Lot Number | E16DI0174 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-11-13 |