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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHOFIX INC. CENTURION POCT SYSTEM; SET SCREW
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ORTHOFIX INC. CENTURION POCT SYSTEM; SET SCREW Back to Search Results
Model Number 69-2001
Device Problems Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 02/20/2018
Event Type  malfunction  
Event Description
Information provided states that during 4 month post-op visit, the surgeon noticed that 4 of the set screws had become loosened.Patient had complained of increased pressure in one area after fall in (b)(6) 2017.A revision surgery was performed on (b)(6) to replace set screws.
 
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Brand Name
CENTURION POCT SYSTEM
Type of Device
SET SCREW
Manufacturer (Section D)
ORTHOFIX INC.
3451 plano parkway
lewisville TX 75056
Manufacturer (Section G)
ORTHOFIX INC.
3451 plano parkway
lewisville TX 75056
Manufacturer Contact
yolanda thompson
3451 plano parkway
lewisville, TX 75056
2149372291
MDR Report Key7351987
MDR Text Key103282075
Report Number2183449-2018-00006
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150822
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number69-2001
Device Lot NumberS32
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/20/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/19/2017
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 Age48 YR
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