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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 480MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 480MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 196789480
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative

Additional device product codes: kwp, osh, mnh, kwq, mni. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient was operated dorsally on the lumbar spine on (b)(6) 2020 due to a subsequent degeneration. It was dorsal spondylodesis with ilium connection on both sides l3 ilium, expedium si & cfx implants, cocr rod. Years ago, due to a scoliotic deformity of the spine, the patient was provided with a long screw-rod stabilization with ventro-lateral access (competitor system, system unknown). On (b)(6) 2020, the patient underwent revision surgery due to a broken cocr rod. The fracture of this rod was noted in the area l5 / left in the area of ¿¿the screw head of the expedition implant. No further information provided. Concomitant device reported: setscrew (part# unknown, lot# unknown, quantity unknown); screw (part# unknown, lot# unknown, quantity unknown). This report is for one (1) expedium and viper 2 spine system rod, straight 5. 5 x 480mm. This is report 1 of 1 for complaint (b)(4).

 
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Brand NameEXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, STRAIGHT 5.5 X 480MM
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 Key11096923
MDR Text Key224542244
Report Number1526439-2020-02508
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK111136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number196789480
Device Catalogue Number196789480
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 Received01/06/2021
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?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/30/2020 Patient Sequence Number: 1
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