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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH VERSE CORRECTION KEY ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Tissue Damage (2104)
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 is a revision case report. The 8 mm screw and iliac connector from the right side were removed due to protrusion which resulted in penetration of the skin of the patient and infection. The primary surgery was done in (b)(6) 2019. The patient has lost 20 kg of body weight in the last 5 months and is a heavy smoker. The protrusion of the screw was not evident at the time of the surgery. The products involved had to be left in the hospital for sterilization (code 1997-21-8xx and 1997-21-000) and might be returned for analysis if the hospital allows. I will have that information on monday, 30th september. Code 1797-98-100 will not be returned as it will be used for analysis of the infection (sonification). This complaint involve three (3) devices.
 
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Brand NameVERSE CORRECTION KEY
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9217590
MDR Text Key176545730
Report Number1526439-2019-52262
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 09/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number199721000
Device Catalogue Number199721000
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 Received09/27/2019
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? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/22/2019 Patient Sequence Number: 1
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