MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL SCREW 6 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 179712645

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vertebral Fracture (4520)

Event Type  Injury  

Manufacturer Narrative

Additional procodes: kwp, kwq, mnh, mni, osh.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 Description

Device report from (b)(6) reports an event as follows: it was reported that patient experienced fracture of the posterior 1/3 of the l1 vertebral body after being implanted with expedium screws.This report is for an expedium single inner polyaxial screw.This is report 5 of 6 for (b)(4).

• Brand Name: SI POLYAXL SCREW 6 X 45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 11314045
• MDR Text Key: 231390834
• Report Number: 1526439-2021-00277
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034067735
• UDI-Public: (01)10705034067735
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 179712645
• Device Catalogue Number: 179712645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2021
• 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: SI POLYAXL SCREW 6 X 45MM; SI POLYAXL SCREW 6 X 45MM; SI POLYAXL SCREW 6 X 45MM; SI POLYAXL SCREW 6 X 45MM; SI POLYAXL SCREW 6 X 45MM
• Patient Outcome(s): Required Intervention