MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-05 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).
[177829840]
The distributor of this product incorrectly has identified theirself as the manufacturer of this device and submitted report number, 2939274-2019-57759, on their behalf. The device was not returned to rti surgical for evaluation. A dhr review was conducted and confirms the device met manufacturing specification prior to shipping from rti surgical facility. This report will be updated should additional information become available at a later date. Sex, weight, ethnicity, race have been left blank as this information could not be obtained in this investigation.
Patient Sequence No: 1, Text Type: N, H10
[177829841]
It was reported to rti surgical on 1/09/2020 that the patient underwent a revision on (b)(6) 2012 due to infection where iv antibiotics were required. Index surgery was originally performed on (b)(6) 2007. Further occurence and patient information could not be obtained. This report will be updated should additional information become available at a later date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833824-2020-00008 |
| MDR Report Key | 9670928 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date of Event | 2012-09-25 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-05 |
| 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 | 2020-02-05 |
| Model Number | 401-146 |
| Catalog Number | 611.105.01S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2020-02-05 |