MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN LOCKING/SET SCREWS; SCREW,FIXATION,BONE

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking/set screws /unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(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 Description

It was reported that on (b)(6) 2020, an add-on revision of t1-s1 scoliosis procedure was completed.Initially it was a t6-s2 fusion completed on an unknown date in 2010.The surgery was to extend the fusion of the construct from t1-t6 as the patient's spine kyphosis due to adjacent level disease.The rods and set screws were removed and replaced since the rods needed to be bigger for the extension.The sets screws removed were depuy spine expedium.The procedure was successfully completed.The patient outcome was good.This report is for one (1) unknown locking/set screws.This is report 3 of 3 for (b)(4).

• Brand Name: UNKNOWN LOCKING/SET SCREWS
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9597830
• MDR Text Key: 189445807
• Report Number: 1526439-2020-00398
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2020
• 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
• Patient Outcome(s): Required Intervention