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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
Product complaint #: (b)(4). This complaint was generated from literature review conducted in post market surveillance (pms) for health authority reporting purposes. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the pms 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: rigid occipitocervical fixation: indications, outcomes and complications of the modern era. Robin bhatia, ph. D. , f. R. C. S. (sn), ruth m. Desouza, m. R. C. S. , jonathan bull, f. R. C. S. (sn), and adr ian t. H. Casey, f. R. C. S. (sn) department of neurosurgery, the national hospital for neurology and neurosurgery, queen. Broken rod and 1 loose screw, two screw pull out, two broken rods and 1 loose screw, broken rod.
 
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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 dr.
raynham, MA 02767
5088808100
MDR Report Key7646420
MDR Text Key112706388
Report Number1526439-2018-50610
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 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
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 Received06/04/2018
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 Unkown

Patient Treatment Data
Date Received: 06/28/2018 Patient Sequence Number: 1
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