MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-04 for CABLE, 1.7MM,W/CRIMP,1-PK,CO-CR, SYNTHES 401-146 611.105.01S manufactured by Pioneer Surgical (d.b.a. Rti Surgical).
| Report Number | 1833824-2020-00005 |
| MDR Report Key | 9667452 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-04 |
| Date of Event | 2019-04-10 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2018-03-02 |
| Date Added to Maude | 2020-02-04 |
| 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. DANIEL NELSON |
| Manufacturer Street | 375 RIVER PARK CIRCLE |
| Manufacturer City | MARQUETTE MI 49855 |
| Manufacturer Country | US |
| Manufacturer Postal | 49855 |
| Manufacturer G1 | PIONEER SURGICAL (D.B.A. RTI SURGICAL) |
| Manufacturer Street | 375 RIVER PARK CIRCLE |
| Manufacturer City | MARQUETTE MI 49855 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49855 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE, 1.7MM,W/CRIMP,1-PK,CO-CR, SYNTHES |
| Generic Name | CERCLAGE FIXATION CABLE |
| Product Code | JDQ |
| Date Received | 2020-02-04 |
| Model Number | 401-146 |
| Catalog Number | 611.105.01S |
| Lot Number | P308469 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PIONEER SURGICAL (D.B.A. RTI SURGICAL) |
| Manufacturer Address | 375 RIVER PARK CIRCLE MARQUETTE MI 49855 US 49855 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-04 |