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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, 2.4 X 34MM, CORTICAL PLATE, FIXATION, BONE

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ARTHREX, INC. LOW PROFILE SCREW, 2.4 X 34MM, CORTICAL PLATE, FIXATION, BONE Back to Search Results
Model Number LOW PROFILE SCREW, 2.4 X 34MM, CORTICAL
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
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 during a procedure, the ar-18724-34 from mini cfs set popped through the plate when the surgeon was screwing it in the patient. The surgeon first used power and finished tightening by hand. No additional information provided. Additional information requested.
 
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Brand NameLOW PROFILE SCREW, 2.4 X 34MM, CORTICAL
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 Key11991309
MDR Text Key259469168
Report Number1220246-2021-03279
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191344
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 06/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLOW PROFILE SCREW, 2.4 X 34MM, CORTICAL
Device Catalogue NumberAR-18724-34
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
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

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