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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. COMPR FT SCRW,4.0 STD,30MM LGTH PLATE, FIXATION, BONE

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ARTHREX, INC. COMPR FT SCRW,4.0 STD,30MM LGTH PLATE, FIXATION, BONE Back to Search Results
Model Number COMPR FT SCRW,4.0 STD,30MM LGTH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)
Event Date 07/12/2021
Event Type  Injury  
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.

 
Event Description

It was reported after 12 weeks post op from bunion surgery on (b)(6) 2021 the patient is experiencing swelling. Three screws were implanted and the patient feels she could be having an allergic reaction. The patient was in a hard cast for the first 30 days then to a walking boot at the 4th week. During the time right after the cast removal her foot became quite swollen and she experienced more than a moderate amount of pain. The patient elevated and iced the foot which relieved the pain to a tolerable amount but the swelling never went away. The patient is concerned she has a sensitivity to metal which could be causing this issue.

 
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Brand NameCOMPR FT SCRW,4.0 STD,30MM LGTH
Type of DevicePLATE, FIXATION, BONE
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
vik bajnath
8009337001
MDR Report Key12267155
MDR Text Key264929164
Report Number1220246-2021-03454
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK201132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation ADMINISTRATOR/SUPERVISOR
Type of Report Initial
Report Date 08/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCOMPR FT SCRW,4.0 STD,30MM LGTH
Device Catalogue NumberAR-8740-30H
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2021
Was Device Evaluated By Manufacturer? No Answer Provided
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: 08/03/2021 Patient Sequence Number: 1
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