MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-12 for TM ARDIS® INTERBODY SYSTEM SOLID N/A 0670201071 manufactured by Zimmer Tmt.
| Report Number | 3005751028-2019-00039 |
| MDR Report Key | 9311061 |
| Date Received | 2019-11-12 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-07-16 |
| Date Mfgr Received | 2019-10-21 |
| Device Manufacturer Date | 2016-06-28 |
| Date Added to Maude | 2019-11-12 |
| 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. WILLIAM HARA |
| Manufacturer Street | 10 POMEROY ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9735760032 |
| Manufacturer G1 | ZIMMER TMT |
| Manufacturer Street | 10 POMEROY ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TM ARDIS® INTERBODY SYSTEM SOLID |
| Generic Name | PROSTHESIS, SPINE |
| Product Code | MAX |
| Date Received | 2019-11-12 |
| Model Number | N/A |
| Catalog Number | 0670201071 |
| Lot Number | 63392062 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER TMT |
| Manufacturer Address | 10 POMEROY ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-12 |