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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS TULIP; ILIAC SCREW
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MEDICREA INTERNATIONAL PASS TULIP; ILIAC SCREW Back to Search Results
Model Number B22028580
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2020
Event Type  malfunction  
Event Description
2 tulip screws implanted on (b)(6) 2019 in iliac area.On (b)(6) patients films show broken/caps.During revision tulips were completely sheered off from shank on both sides at the same spot.Screws were explanted on (b)(6) 2020.
 
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Brand Name
PASS TULIP
Type of Device
ILIAC SCREW
Manufacturer (Section D)
MEDICREA INTERNATIONAL
5389 route de strasbourg
rillieuz-la-pape, 69140
FR  69140
Manufacturer (Section G)
MEDICREA INTERNATIONAL
5389 route de strasbourg
rillieux la pape, 69140
FR   69140
Manufacturer Contact
karine trogneux
5389 route de strasburg
rillieux la pape, 69140
FR   69140
MDR Report Key9781982
MDR Text Key190773088
Report Number1000432246-2020-00002
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/05/2020,03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberB22028580
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/04/2020
Event Location Hospital
Date Report to Manufacturer02/05/2020
Date Manufacturer Received02/06/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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