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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC.; BONE FIXATION SCREW/PLATE
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ARTHREX, INC.; BONE FIXATION SCREW/PLATE Back to Search Results
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Failure of Implant (1924)
Event Date 01/05/2024
Event Type  malfunction  
Event Description
On 01/05/2024, it was reported by a patient via email that an unknown fixation plate had broken and one of the screws is backing out of the bone.This occurred after use in a case, patient affects unknown."i had bunion surgery in (b)(6) 2023 and they used one of your plates.Three months post surgery all was good, about three months later the screw they used was coming out of the side of my toe.Further xrays show the plate(yours) was broken." additional information requested on 1/12/24.
 
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
 
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Brand Name
UNK
Type of Device
BONE FIXATION SCREW/PLATE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
emily shafer
8009337001
MDR Report Key18615778
MDR Text Key334222192
Report Number1220246-2024-00648
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received01/05/2024
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
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