MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 4.35 X 35MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186731435
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Paralysis (1997)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: mni, kwq, kwp, and mnh.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Initial reporter facility name: (b)(6).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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the screw at the t6 pedicle had cut out and deviated into the spinal canal.On (b)(6) 2020 the patient underwent a posterior spinal fusion, screws were deployed at t6 left, t7 and t8.At the end of (b)(6) 2021, the patient experienced paralysis in the lower limbs due to the migration of the screw.On (b)(6) 2021 the screw that had migrated was removed.Concomitant device reported: rod (part number unknown, lot unknown, quantity unknown); screw (part number unknown, lot unknown, quantity unknown).This report involves one (1) viper system cortical fix polyaxial screw 5.5 4.35 x 35mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: e1: facility name.Investigation summar: product was not returned.Based on the information available, it has been determined that no corrective and 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 35MM
• 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: 11377820
• Report Number: 1526439-2021-00357
• Device Sequence Number: 3785977
• Product Code: NKB
• UDI-Device Identifier: 10705034351414
• UDI-Public: (01)10705034351414
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: 186731435
• Device Catalogue Number: 186731435
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 TI CORT FIX 4.35X35MM.; UNKNOWN RODS.; UNKNOWN RODS.; UNKNOWN SCREWS.; UNKNOWN SCREWS.; UNKNOWN RODS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention