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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC.; TOT ANAT SHOULDR PROSTH, UNCEM
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ARTHREX, INC.; TOT ANAT SHOULDR PROSTH, UNCEM Back to Search Results
Device Problem Insufficient Information (3190)
Event Date 12/19/2023
Event Type  Injury  
Event Description
On 12/21/2023, it was reported by a sales representative via email that a patient underwent a proceudre on (b)(6) 2022 in which the eclipse implant system was used.On 12/19/2023, the patient underwent revision surgery due to an infection and had antibiotic spacers placed.Different surgeons performed the surgeries.No further information was reported.Additional information requested.
 
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
TOT ANAT SHOULDR PROSTH, UNCEM
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 Key18506509
MDR Text Key332873041
Report Number1220246-2024-00334
Device Sequence Number1
Product Code QHQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183194
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 01/12/2024
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
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/21/2023
Initial Date FDA Received01/12/2024
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
Patient Outcome(s) Other; Required Intervention;
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