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 TRD, STANDARD, ASSY,STRL SYNTHES 401-033 498.806S manufactured by Pioneer Surgical (d.b.a. Rti Surgical).
[178530364]
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 identifier, age or date of birth, sex, weight, ethnicity, race, implant date, explant date have been left blank as this information could not be obtained in this investigation.
Patient Sequence No: 1, Text Type: N, H10
[178530365]
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 | 1833824-2020-00013 |
| MDR Report Key | 9689372 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2017-01-05 |
| 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 | TRD, STANDARD, ASSY,STRL SYNTHES |
| Generic Name | CERCLAGE FIXATION |
| Product Code | JDQ |
| Date Received | 2020-02-10 |
| Model Number | 401-033 |
| Catalog Number | 498.806S |
| Lot Number | P252359 |
| 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 |