MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, LORDOSED 5.5 X 120MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 196788120

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, the rods were broken during reverse logistics audit of returned device at a third party servicer.There was no patient involvement and no additional information is available.This report is for one (1) expedium and viper 2 spine system rod, lordosed 5.5 x 120mm.This is report 3 of 3 for (b)(4).

Manufacturer Narrative

Additional procode: kwp, nkb, kwq, osh, mnh.The device was 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: EXPEDIUM AND VIPER 2 SPINE SYSTEM ROD, LORDOSED 5.5 X 120MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: 12815321
• MDR Text Key: 285694547
• Report Number: 1526439-2021-02411
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034182537
• UDI-Public: 10705034182537
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 196788120
• Device Catalogue Number: 196788120
• Device Lot Number: UI107490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2009
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: OC ADJ ROD LOPRO 3.5 X 220 - 7.; ROD, 300 MM.