CROSSTEX TYVEK INTRAARTICULAR DEVICE TSP-185

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report NumberMW5092658
MDR Report Key9653637
Date Received2020-01-30
Date of Report2020-01-28
Date of Event2020-01-23
Date Added to Maude2020-01-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCROSSTEX TYVEK INTRAARTICULAR DEVICE
Generic NameWRAP STERIZATION
Product CodeFRG
Date Received2020-01-30
Model NumberTSP-185
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCROSSTEX INTERNATIONAL, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-30

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