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 |