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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. VALOR(R) SCREW; SMALL JOINT COMPONENT

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WRIGHT MEDICAL TECHNOLOGY, INC. VALOR(R) SCREW; SMALL JOINT COMPONENT Back to Search Results
Catalog Number 4151150035
Device Problems Difficult to Insert (1316); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/14/2016
Event Type  malfunction  
Manufacturer Narrative
This investigation is not complete.This report will be updated when the investigation is complete.The surgery time was extended.This is the same event as 1043534-2016-00028 and 1043534-2016-00038.
 
Event Description
It was reported that the compression screw got jammed inside the implant.Compression could not be achieved and the posterior screw could not be inserted.In the end they could remove the compression screw and a new implant was used.
 
Manufacturer Narrative
This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.
 
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Brand Name
VALOR(R) SCREW
Type of Device
SMALL JOINT COMPONENT
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
1023 cherry road
memphis, TN 38117
901451-631
MDR Report Key5721128
MDR Text Key48414484
Report Number1043534-2016-00039
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K090857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number4151150035
Device Lot Number1557910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/05/2016
Initial Date FDA Received06/13/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/09/2016
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Age39 YR
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