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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PLATE; PLATE, FIXATION, BONE

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PLATE; PLATE, FIXATION, BONE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
It was reported that on an unknown date, the surgeon had a couple of non union humerus fracture cases for revision.One was for sure a stryker construct and the other had an unknown manufacturer plates and screws.It is unknown if the procedure was completed successfully.There were patient consequences.Reference report: mw5119160.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
Event Description
It was reported that on an unknown date, the surgeon had a couple of non union humerus fracture cases for revision.One was for sure a stryker construct and the other had an unknown manufacturer plates and screws.It is unknown if the procedure was completed successfully.There were patient consequences.Reference report: mw5119160.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
PLATE
Type of Device
PLATE, FIXATION, BONE
MDR Report Key17278421
MDR Text Key318616921
Report NumberMW5119159
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 06/29/2023
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? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/06/2023
Patient Sequence Number1
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