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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 186760050
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Visual inspection performed at customer quality (cq) showed the x-tab portion of the implant had broken off from the proximal end. No other issues were identified. A device failure was identified. No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown. During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history lot : product code: 186760050, lot number: 171337. Device history review: the dhr of product code 186760050, lot 171337, was reviewed and no non-conformance were observed during the manufacturing process. The product was released on november 29, 2017. The dhr was electronically reviewed. 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
It was reported that on an unknown date, two units of mis cannulated x-tab 6x50mm ti were received and identified that the x-tab on both devices were cut off. There is no patient involvement. Procedure outcome is unknown. This report is for one (1) viper system cannulated extended tab poly screw 5. 5 x 6. 0 x 50mm. This is report 2 of 2 for (b)(4).
 
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Brand NameVIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 6.0 X 50MM
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
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key11627771
MDR Text Key245381373
Report Number1526439-2021-00645
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034129211
UDI-Public(01)10705034129211
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186760050
Device Catalogue Number186760050
Device Lot Number171337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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