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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 22.0MM HEAD, LEFT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
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ACUMED LLC 22.0MM HEAD, LEFT; PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD Back to Search Results
Model Number TR-H220L-S
Device Problem Component Missing (2306)
Patient Problem No Code Available (3191)
Event Date 03/29/2018
Event Type  malfunction  
Event Description
An arh solutions radial head replacement implant was being used in surgery.The head sterile package was opened and the head was found to have no laser alignment line.The head was implanted, using the trial to determine proper orientation.This prolonged surgery by 15 minutes.
 
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Brand Name
22.0MM HEAD, LEFT
Type of Device
PROSTHESIS, ELBOW, HEMI-, RADIAL, HEAD
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer (Section G)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer Contact
micki lehman
5885 ne cornelius pass road
hillsboro, OR 97124
8886279957
MDR Report Key7435629
MDR Text Key105895043
Report Number3025141-2018-00183
Device Sequence Number1
Product Code KWI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131845
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date03/31/2022
Device Model NumberTR-H220L-S
Device Catalogue NumberTR-H220L-S
Device Lot Number347512
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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