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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR SCREW 5.0MM X 30MM LEN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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WRIGHT MEDICAL TECHNOLOGY INC VALOR SCREW 5.0MM X 30MM LEN ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 4151150030
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Non-union Bone Fracture (2369)
Event Date 11/16/2021
Event Type  Injury  
Event Description
It was reported that the im nail loosened and caused infection that led to a nonunion of the ankle fusion site. It required removal of the im nail with bone biopsies and placement of antibiotic cement nail with iv antibiotics followed by revision of ankle fusion with external fixator.
 
Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated. Device not available.
 
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Brand NameVALOR SCREW 5.0MM X 30MM LEN
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY INC
1023 cherry rd
memphis TN 38117
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key13523909
MDR Text Key285607505
Report Number3010667733-2022-00065
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090857
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4151150030
Device Catalogue Number4151150030
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/14/2022 Patient Sequence Number: 1
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