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 2020-02-27 for 1.7MM CABLE WITH CRIMP 750MM 298.801.01 manufactured by Rti Surgical.
| Report Number | 1833824-2020-00029 |
| MDR Report Key | 9763348 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-27 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-10-10 |
| Date Added to Maude | 2020-02-27 |
| 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 | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.7MM CABLE WITH CRIMP 750MM |
| Generic Name | CERCLAGE FIXATION |
| Product Code | JDQ |
| Date Received | 2020-02-27 |
| Catalog Number | 298.801.01 |
| Lot Number | P343573 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RTI SURGICAL |
| Manufacturer Address | 375 RIVER PARK CIRCLE MARQUETTE MI 49855 US 49855 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |