MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186731740
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: additional device product codes: mnh; mni; kwp; kwq.Complainant part is not expected to be returned for manufacturer review/investigation.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.
Event or Problem Description
It was reported that a patient had posterior spinal fusion surgery done on (b)(6) 2021.The patient underwent a revision surgery on (b)(6) 2021 as the patient was having complication from a right side s1 pedicle screw.The patient was experiencing right side leg pain.The screw was removed and new implants were put in.Procedure outcome is unknown.This report is for one (1) viper system cortical fix polyaxial screw 5.5 7 x 40mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12378820
• Report Number: 1526439-2021-01794
• Device Sequence Number: 4407311
• Product Code: NKB
• UDI-Device Identifier: 10705034352008
• UDI-Public: (01)10705034352008
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186731740
• Device Catalogue Number: 186731740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2021
• Initial Report FDA Received Date: 08/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention