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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI I/M ROD LINK

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BIOMET UK LTD. OXF UNI I/M ROD LINK Back to Search Results
Model Number N/A
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that the im link instrument broke into two piece during insertion into the im rod.
 
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Brand NameOXF UNI I/M ROD LINK
Manufacturer (Section D)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer (Section G)
BIOMET UK LTD.
waterton industrial estates
bridgend CF31 3XA
UK CF31 3XA
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key7215574
MDR Text Key98413229
Report Number3002806535-2018-00155
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PNA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number32-422822
Device Lot NumberZB161001
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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