MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-10 for CABLE, 1.7MM,W/CRIMP, 1-PK, SS, SYNTHES 400-798 298.801.01S manufactured by Pioneer Surgical (d.b.a. Rti Surgical).
[178637419]
This report is a follow-up to an already existing report. The distributor of this product incorrectly has identified theirself as the manufacturer of this device and submitted report number, 2939274-2019-62136, 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 information become available at a later date.
Patient Sequence No: 1, Text Type: N, H10
[178637420]
It was reported to rti surgical on (b)(6) 2020 that there was a patient who underwent a revision on an unknown date due to 2 stage infection related to a previous hip surgery. It is unknown when index surgery was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833824-2020-00011 |
| MDR Report Key | 9689782 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2018-07-16 |
| Date Added to Maude | 2020-02-10 |
| 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 | DANIEL NELSON |
| Manufacturer Street | 375 RIVER PARK CIRCLE |
| Manufacturer City | MARQUETTE, MI |
| Manufacturer Country | US |
| Manufacturer G1 | PIONEER SURGICAL |
| Manufacturer Street | 375 RIVER PARK CIRCLE |
| Manufacturer City | MARQUETTE, MI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE, 1.7MM,W/CRIMP, 1-PK, SS, SYNTHES |
| Generic Name | CERCLAGE FIXATION CABLE |
| Product Code | JDQ |
| Date Received | 2020-02-10 |
| Model Number | 400-798 |
| Catalog Number | 298.801.01S |
| Lot Number | P309113 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-10 |