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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL PLATE, FIXATION, BONE

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ARTHREX, INC. PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL PLATE, FIXATION, BONE Back to Search Results
Model Number PLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 02/14/2022
Event Type  malfunction  
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 that the device broke after implantation. The device was implanted on the (b)(6) 2021 and on the (b)(6) 2022 the device was explanted. No further information received.
 
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Brand NamePLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
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 Key13995012
MDR Text Key288499507
Report Number1220246-2022-04692
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00888867007703
UDI-Public00888867007703
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K032187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 08/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPLATE, OPENING WEDGE OSTEOTOMY, FEMORAL
Device Catalogue NumberAR-13100T-17.5
Device Lot Number13102248
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/04/2022 Patient Sequence Number: 1
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