MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 9X100MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 179704999

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Additional product code: kwp;kwq;mnh;mni.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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, the patient had a surgery for posterior spinal fusion in (b)(6) of 2020.At a follow up appointment in (b)(6) of 2020, xray images showed that the set screw had loosened from the sai screws bilaterally and the rod had loosened due to head splay.The s1 and l5 screws had fractured at the neck of the screw just below the tulip.It is unknown if fragments were generated.The patient did not achieve a fusion below l5 due to this hardware failure.Procedure outcome is unknown.This complaint involves five (5) devices.This report is for (1) viper ti sai poly 9x100mm.This report is 3 of 5 for (b)(4).

• Brand Name: VIPER TI SAI POLY 9X100MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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, MA ; SZ ; 6103142063
• MDR Report Key: 12354169
• MDR Text Key: 267681393
• Report Number: 1526439-2021-01748
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265889
• UDI-Public: 10705034265889
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179704999
• Device Catalogue Number: 179704999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2021
• 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
• Treatment: 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X45MM; VIPER TI SAI POLY 9X90MM
• Patient Outcome(s): Required Intervention