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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS

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MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS Back to Search Results
Device Problem Break (1069)
Patient Problem Spinal Column Injury (2081)
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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
This report is being filed after the subsequent review of the following literature article: cervical klippel-feil syndrome progressing to myelopathy following minor trauma min-hong hsieh a, kuang-ting yeh b,c, ing-ho chen b,d, tzai-chiu yu b,d, cheng-huan peng b, kuan-lin liu b, wen-tien wu b,d,* tzu chi medical journal 26 (2014) 47e50. Received 14 august 2012, received in revised form, 27 august 2012, accepted 13 september 2012. N
=
1: rod breakage (qty 2).
 
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Brand NameUNKNOWN RODS
Type of DeviceUNKNOWN
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ
Manufacturer Contact
jason busch
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7713613
MDR Text Key114820093
Report Number1526439-2018-50705
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 07/24/2018 Patient Sequence Number: 1
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