MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 5 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	186727540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).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 on an unknown date that the patient underwent a revision surgery for pseudarthrosis and correction of sagital balance, the patient has had spinal surgery many times before by different spine surgeons.It was observed that three (3) of the thoracal screws from a previous surgery, levels th9 and th12, all perforated and cemented cfx 5.0mm were broken in the middle part of the screw shaft, just about at the first perforation.This report is for one (1) viper system fenestrated cortical fix polyaxial screw 5.5 x 5 x 40mm.This is report 1 of 3 for (b)(4).

• Brand Name: VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 5 X 40MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12446791
• Report Number: 1526439-2021-01893
• Device Sequence Number: 3420604
• Product Code: MNI
• UDI-Device Identifier: 10705034282442
• UDI-Public: 10705034282442
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 08/12/2021

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: 186727540
• Device Catalogue Number: 186727540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 09/09/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS TI CFX FEN POLY 5X40; MIS TI CFX FEN POLY 5X40; UNK - CONNECTOR; UNKNOWN BIOMATERIAL - CEMENT; UNKNOWN RODS
• Outcome Attributed to Adverse Event: Required Intervention