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

Model Number	179704880
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: VIPER SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9437187
• Report Number: 1526439-2019-52640
• Device Sequence Number: 4202778
• Product Code: NKB
• UDI-Device Identifier: 10705034265728
• UDI-Public: (01)10705034265728
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 179704880
• Device Catalogue Number: 179704880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention