MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186770045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2022 during a revision procedure, two viper prime screws were replaced as the distal tips both broke.This report is for a viper system cannulated extended tab poly screw 5.5 x 7.0 x 45mm.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional procode: mnh, mni, osh, nkb, kwp.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.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 CANNULATED EXTENDED TAB POLY SCREW 5.5 X 7.0 X 45MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14753922
• Report Number: 1526439-2022-00895
• Device Sequence Number: 11309601
• Product Code: KWQ
• UDI-Device Identifier: 10705034129679
• UDI-Public: (01)10705034129679
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 186770045
• Device Catalogue Number: 186770045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS CANNULATED X-TAB 7X45MM TI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 100 KG