MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM ROD 5.5 X 300MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	179762300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that on (b)(6) 2021, the rods were broken during reverse logistics audit of returned device at a third party service.There was no patient involvement and no additional information is available.This report is for one (1) expedium spine system rod 5.5 x 300mm.This is report 2 of 3 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM ROD 5.5 X 300MM
• Common Device Name: 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: 12815128
• Report Number: 1526439-2021-02408
• Device Sequence Number: 5575513
• Product Code: MNI
• UDI-Device Identifier: 10705034077420
• UDI-Public: 10705034077420
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 179762300
• Device Catalogue Number: 179762300
• Device Lot Number: BDBK2SM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 11/17/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/15/2021; 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/08/2007
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OC ADJ ROD LOPRO 3.5 X 220 - 7; VIPER2 LORD. ROD120MM, COCR
• Patient Sex: Unknown