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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICREA INTERNATIONAL PASS XS; POLYAXIAL PEDICLE SCREW
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MEDICREA INTERNATIONAL PASS XS; POLYAXIAL PEDICLE SCREW Back to Search Results
Model Number 4 MM DIAM X 25 MM LONG
Device Problems Fracture (1260); Material Separation (1562)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Date 05/30/2018
Event Type  malfunction  
Manufacturer Narrative
One year post-op from pedicle screw implantation, one of the screws broke just under the screw head.An intervention was required to remove the screw.Part of the broken screw was not able to be removed and remains in the bone.
 
Event Description
One year post-op from pedicle screw implantation, one of the screws broke just under the screw head.An intervention was required to remove the screw.Part of the broken screw was not able to be removed and remains in the bone.
 
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Brand Name
PASS XS
Type of Device
POLYAXIAL PEDICLE SCREW
Manufacturer (Section D)
MEDICREA INTERNATIONAL
5389 route de strasbourg
rillieux-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 strasbourg
rillieux-la-pape, 69140
FR   69140
MDR Report Key7645965
MDR Text Key112891596
Report Number1000432246-2018-00009
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K160640
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model Number4 MM DIAM X 25 MM LONG
Device Catalogue NumberB19114025
Device Lot Number16C0501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? No
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;
Patient Age12 YR
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