MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5 ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 279734000N

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/13/2021

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2021, when surgeon was instrumenting for an l5-s1 construct on a patient with sclerotic bone. The expedium navigation broke at the tip when inserting the third screw. The screw was fully seated at the time. The fragment could not be retrieved and the surgeon proceeded to instrument the last screw with a new driver and completed the construct. The procedure was successfully completed without surgical delay. There was no patient harm/consequence. This report involves one (1) universal navigation expedium spine system quick connect poly driver 5. 5. This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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: UNIVERSAL NAVIGATION EXPEDIUM SPINE SYSTEM QUICK CONNECT POLY DRIVER 5.5
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): BRIDGEWATER DISTRIBUTION; 50 scotland boulevard; bridgewater MA 02324
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12771108
• MDR Text Key: 280464635
• Report Number: 1526439-2021-02336
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140927
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 279734000N
• Device Catalogue Number: 279734000N
• Device Lot Number: GM5358811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 11/08/2021 Patient Sequence Number: 1

Treatment

UNKNOWN SCREWS