MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-30 for 1.7MM CABLE WITH CRIMP 750MM-STERILE 298.801.01S manufactured by Rti Surgical.
[178110650]
Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is an attorney. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[178110651]
It was reported that on (b)(6) 2019 the patient underwent an emergent incision and drainage and open reduction internal fixation (orif) right tibia due to osteomyelitis and infection. On an unknown date the patient fell with her leg went behind her, fracturing her tibia. She also had an open dehiscence of her surgical wound on the knee. Due to the bend of the knee and the split of the skin, she has been bleeding and has an opening on her knee replacement. On (b)(6) 2019 the patient underwent an open treatment of tibial shaft fracture on the right side with an internal fixation with plate; a secondary closure of the surgical wound dehiscence, and an extensive and complicated 8cm and arthrotomy knee with exploration and drainage of the right knee, where the knee replacement is located.. This report is for one (1) 1. 7mm cable with crimp 750mm-sterile. This is report 3 of 10 for (b)(4). This report is linked to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833824-2020-00002 |
| MDR Report Key | 9646897 |
| Report Source | OTHER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-01-08 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 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-STERILE |
| Generic Name | CERCLAGE FIXATION |
| Product Code | JDQ |
| Date Received | 2020-01-30 |
| Catalog Number | 298.801.01S |
| Lot Number | P326835 |
| 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 | 2020-01-30 |