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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS KOROS SELF RETAIN RTRCTR SET; RETRACTOR
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BIOMET ORTHOPEDICS KOROS SELF RETAIN RTRCTR SET; RETRACTOR Back to Search Results
Catalog Number 31-555590
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 03/13/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the packaging of the self retaining retractors was missing components.No adverse event was reported as a result of this malfunction.
 
Manufacturer Narrative
This report is being submitted to relay corrected information.Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event, as there was no failure of the device.
 
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Brand Name
KOROS SELF RETAIN RTRCTR SET
Type of Device
RETRACTOR
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6635227
MDR Text Key77500367
Report Number0001825034-2017-03849
Device Sequence Number1
Product Code GAD
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
PEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number31-555590
Device Lot Number784270
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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