MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for CROSSTEX TYVEK INTRAARTICULAR DEVICE TSP-185 manufactured by Crosstex International, Inc..
[177584819]
Pt was undergoing a left total knee replacement and while placing the intraarticular device it cracked into several pieces. The wound was inspected and irrigated and area was x-rayed. X-ray was negative and procedure continued without further issues. Zimmer biomet, (b)(4). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5092658 |
MDR Report Key | 9653637 |
Date Received | 2020-01-30 |
Date of Report | 2020-01-28 |
Date of Event | 2020-01-23 |
Date Added to Maude | 2020-01-31 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Reporter Occupation | RISK MANAGER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | CROSSTEX TYVEK INTRAARTICULAR DEVICE |
Generic Name | WRAP STERIZATION |
Product Code | FRG |
Date Received | 2020-01-30 |
Model Number | TSP-185 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CROSSTEX INTERNATIONAL, INC. |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2020-01-30 |