MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 179702000S

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 the (b)(6) reports an event as follows: it was reported that during a procedure on an unknown date, the surgeon was unable to final tighten the set screws; the tip was spinning and not reaching torque limit.An alternative instrument was opened and used to lock remaining set screws and procedure was completed successfully.Procedure was completed with a delay of less than two (2) minutes.There was no patient consequence.This report is for an expedium single-inner setscrew.This is report 1 of 1 for (b)(4).

Event Description

This is report 2 of 2 for (b)(4).

• Brand Name: SINGLE-INNER SETSCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11154514
• MDR Text Key: 226854179
• Report Number: 1526439-2021-00136
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265063
• UDI-Public: (01)10705034265063
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702000S
• Device Catalogue Number: 179702000S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN SCREWS; X25 FINAL TIGHTENER