Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; TOTAL SHOULDER ARTHROPLASTY SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM; TOTAL SHOULDER ARTHROPLASTY SYSTEM Back to Search Results
Model Number ECLIPSE CAGE SCREW M, 35MM
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Abrasion (1689)
Event Date 10/01/2020
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.
 
Event Description
It was reported that the peg glenoid ar-9105-02 became loose through abrasion.The following components are involved.Ar-9102-02 w.Batch unk, ar-9300-43cpc w.Batch 12315, ar-9301-02 w.Batch 12537, ar-9343-16 w.Batch 11295131006.Devices will be returned for investigation, therefore, revision surgery has been performed.No further information has been provided.
 
Manufacturer Narrative
Complaint not confirmed, no abnormalities were observed on the device that may have contributed to the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ECLIPSE CAGE SCREW M, 35MM
Type of Device
TOTAL SHOULDER ARTHROPLASTY SYSTEM
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key10786993
MDR Text Key214617024
Report Number1220246-2020-02316
Device Sequence Number1
Product Code QHQ
Combination Product (y/n)N
PMA/PMN Number
K183194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberECLIPSE CAGE SCREW M, 35MM
Device Catalogue NumberAR-9301-02
Was Device Available for Evaluation? Yes
Date Manufacturer Received10/19/2020
Patient Sequence Number1
Patient Outcome(s) Other;
-
-