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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. GLENOID K-WIRE, 3MM X 250MM
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EXACTECH, INC. GLENOID K-WIRE, 3MM X 250MM Back to Search Results
Catalog Number 313-35-00
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 09/08/2014
Event Type  Injury  
Manufacturer Narrative
Pending evaluation.
 
Event Description
Index surgery (b)(6) 2014.Revision due to glenoid side pain.
 
Event Description
It was reported by the patient that a "reem and run operation" on (b)(6) 2014.The patient stated "the cap was mislabeled for size.Due to imobility and pain, it was removed in (b)(6) 2015 and replaced with a full shoulder replacement." associated mfrs: 1038671-2017-00335, 1038671-2017-00336, 1038671-2017-00337.
 
Manufacturer Narrative
Associated mfrs: 1038671-2017-00335, 1038671-2017-00336, 1038671-2017-00337.Conclusion code: all patients should be instructed on the limitations of the prosthesis and the possibility of subsequent surgery.The event of pain/discomfort is greater than 3 months postop and it is highly unlikely to be related to the surgical procedure or devices.The most likely cause of the reported event is related to the underlying patient condition.This device is for treatment, not diagnosis.
 
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Brand Name
GLENOID K-WIRE, 3MM X 250MM
Type of Device
GLENOID
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
MDR Report Key7460992
MDR Text Key106516214
Report Number1038671-2018-00338
Device Sequence Number1
Product Code HSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/19/2022
Device Catalogue Number313-35-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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