MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 186731440

Device Problem Break (1069)

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

Event Type  Injury  

Event Description

It was reported that the patient underwent surgery with the implants in question on (b)(6) 2020.On an unknown date, one (1) polyaxial screw broke and one (1) polyaxial screw migrated.The first screw broke where the screw head meets the screw shank.The second screw pulled out completely.The patient underwent revision surgery on (b)(6) 2021.The patient and procedure outcome are unknown.This report is for one (1) viper system cortical fix polyaxial screw 5.5 4.35 x 40mm.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Event occurred on an unknown date in 2021.Additional procode: nkb, mnh, kwp, kwq.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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.

• Brand Name: VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 40MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12848685
• MDR Text Key: 281386419
• Report Number: 1526439-2021-02448
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034351421
• UDI-Public: 10705034351421
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2021

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
• Device Operator: Health Professional
• Device Model Number: 186731440
• Device Catalogue Number: 186731440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 11/19/2021
• 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 4.35X40MM
• Patient Outcome(s): Required Intervention
• Patient Sex: Male