• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT Back to Search Results
Device Problem Appropriate Term/Code Not Available
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: at 4,5 year infection rate in open spondylodesis with decompression versus the less invasive lis technique in lumbar spine. Authors: pfandlsteiner t. , wimmer c. Source: european spine journal. 2010 nov; conference: 5th german spine conference- annual meeting of the german spine society. Bremen germany. Conference publication: (var. Pagings). 19 (11) :1978. Deep infection (ae only ¿ expedium system) - unknown patients with open mono stabilizations, bi stabilizations, poly-segmental stabilizations and open stabilization (2006-2010); deep infection was evaluated. In all deep infections wide debridement, jet lavage, drainage was done, parenteral antibiotics 7 to 10 days by antibiogram and afterwards oral antibiotics were given. In deep infections in 3 cases s. Aureus, in 4 cases mrse, in 2 case e. Coli and in 1 case mrsa was found. Patient with deep infection needing revision (ae only ¿ expedium system) - in 1 unknown patient with staphylococcus aureus infection, a 2nd revision with debridement, jetlavage, surgical site drainage and antibiotics for 4 months was done. Superficial infection (ae only ¿ expedium system) - unknown patients with open mono stabilizations, bi stabilizations, poly-segmental stabilizations and open stabilization (2006-2010); superficial infection was evaluated. In superficial infections after revision parenteral antibiotics over 3 days, then oral antibiotics depending on the antibiogram were given. In superficial infections in 3 cases s. Aureus, in 1 case e. Coli and in 2 cases mrse was found. Device malfunction (malfunction only ¿ expedium screws) ¿ screw loosening - in unknown patients with open stabilizations; screw loosening was observed.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN SCREW/ROD CONSTRUCT
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 Key7923528
Report Number1526439-2018-50931
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 09/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2018
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received09/04/2018
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: 10/01/2018 Patient Sequence Number: 1
-
-