MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-02-18 for TI LOW PROFILE TRANSCONNECTOR 42MM-55MM FOR 6.0MM RODS 497.798 manufactured by Wrights Lane Synthes Usa Products Llc.
| Report Number | 2939274-2020-00883 |
| MDR Report Key | 9719820 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2010-02-09 |
| Date Added to Maude | 2020-02-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI LOW PROFILE TRANSCONNECTOR 42MM-55MM FOR 6.0MM RODS |
| Generic Name | ORTHOSIS,SPONDYLOSTHESIS SPINAL FIXATION |
| Product Code | MNH |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-01-14 |
| Model Number | 497.798 |
| Catalog Number | 497.798 |
| Lot Number | 6321202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |