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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNKNOWN LOCKING/SET SCREWS

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MEDOS INTERNATIONAL SARL UNKNOWN LOCKING/SET SCREWS Back to Search Results
Device Problem Appropriate Term/Code Not Available
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative

A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

It was reported via (b)(6) communication voicemail. I'm calling from (b)(6) hospital here in (b)(6). We have a surgeon that's put in a fair amount of the interventional spine set screws over the years and we have a patient that is needing one removed. We actually don't have the screwdriver to remove it. So i'm trying to get a hold of someone who can you know maybe overnight us one or something like that. The surgery is scheduled for the (b)(6) any kind of assistance would be great.

 
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Brand NameUNKNOWN LOCKING/SET SCREWS
Type of DeviceUNKNOWN
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle 02400
SZ  02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle
SZ 
Manufacturer Contact
jason busch
325 paramount drive
raynham , MA 02767
5088808100
MDR Report Key7482935
Report Number1526439-2018-50451
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 04/17/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 05/03/2018 Patient Sequence Number: 1
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