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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; PLATE, FIXATION, BONE
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ARTHREX, INC. CLAV FRAC PLT,CENTRAL THIRD,LFT,SS; PLATE, FIXATION, BONE Back to Search Results
Model Number CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Health Effect - Clinical Codes Erythema (1840); Pain (1994); Swelling (2091)
Date of Event 09/03/2020
Type of Reportable Event Serious Injury
Additional 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.
 
Event or Problem Description
It was reported by the patient's legal representative that the patient had an arthrex ar-2653cl clavicle plate (lot 6791442) implanted.On or around (b)(6) 2019 the patient noticed pain, redness and a lump inher clavicle.She proceeded to the emergency room where x-rays were taken demonstrating the plate had broken.The plate was subsequently surgically removed on or around (b)(6) 2019.
 
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Brand Name
CLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Common Device Name
PLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10547374
Report Number1220246-2020-02178
Device Sequence Number3033164
Product Code HRS
UDI-Device Identifier00888867027442
UDI-Public00888867027442
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K143139
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/17/2020
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
Operator of Device Health Professional
Device Model NumberCLAV FRAC PLT,CENTRAL THIRD,LFT,SS
Device Catalogue NumberAR-2653CL
Device Lot Number6791442
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/03/2020
Initial Report FDA Received Date09/17/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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