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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET UK LTD. STD BRL LAG SCRW 12.5X120MM

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BIOMET UK LTD. STD BRL LAG SCRW 12.5X120MM Back to Search Results
Catalog Number 236120
Device Problem Appropriate Term/Code Not Available
Event Date 08/04/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Udi - (b)(4). Medical product - std brl 4-hole plate 135 deg, item 2110-135-004, lot 6224834. Report source, foreign - event occurred in (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated report: 3002806535-2018-001129.

 
Event Description

Hiploc plate and screw did not assemble.

 
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Brand NameSTD BRL LAG SCRW 12.5X120MM
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 Key7952438
Report Number3002806535-2018-01130
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number236120
Device LOT Number2017030215
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/22/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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