MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 8X80MM; VIPER SYSTEM

Model Number 179704880

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Without a lot number the device history records review could not be completed.Product was not returned.(b)(4).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: patient returned to theatre for revision of left sided rod pull out from a viper sai 8x80mm screw.Patient experience a post-op device malfunction and rod disengaged from sai screw.Pt experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing and require revision surgery or hardware removal.Device was explanted due to rod pull out sai screw.Patient status/ outcome / consequences is unknown.Device was disposed of.This report is for one (1) viper ti sai poly 8x80mm.This report is 4 of 5 for (b)(4).

• Brand Name: VIPER TI SAI POLY 8X80MM
• Type of Device: VIPER SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL 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 Key: 9437187
• MDR Text Key: 185232762
• Report Number: 1526439-2019-52640
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265728
• UDI-Public: (01)10705034265728
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179704880
• Device Catalogue Number: 179704880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention