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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH CORTICAL FIX X-TAB 6X40MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH CORTICAL FIX X-TAB 6X40MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 186760140
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Tissue Damage (2104); Not Applicable (3189)
Event Date 06/30/2017
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
On (b)(6) 2017, the tlif surgery was performed by using the expedium viper ii system. The fixed area was l5 - s1. After the surgery, it was found under the x-ray that part of the broken tab of cortical fix x-tab (186760140) at s1 had been left in the patient¿s body. It is not clear when the hospital noticed this event. The surgeon comments as follows. No adverse consequence to the patient has been confirmed after the surgery the patient is postoperatively in a good condition because his/her preoperative paralysis has been improved and the pain as well has completely gone away. No operation to remove the part of the broken tab is required.
 
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Brand NameCORTICAL FIX X-TAB 6X40MM TI
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
jason busch
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7682410
MDR Text Key113798597
Report Number1526439-2018-50650
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Caregivers
Type of Report Initial
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number186760140
Device Catalogue Number186760140
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 Received06/14/2018
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: 07/12/2018 Patient Sequence Number: 1
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