MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH COUGAR LS 18X8X55 LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	189155508
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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
Cougar ls lordotic cage, while on cougar ls inserter, cracked during final placement of cage.Patient consequence? unknown.Action taken for procedure: doctor made attempt to remove cage, upon seeing that broken piece of the cage was wedge (not moving) in the disc space and was within safe parameters, he made the decision to keep the complete cage implanted.Case proceeded without further incident.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.

• Brand Name: COUGAR LS 18X8X55 LORDOTIC
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7607127
• Report Number: 1526439-2018-50564
• Device Sequence Number: 16211973
• Product Code: MAX
• UDI-Device Identifier: 10705034165387
• UDI-Public: (01)10705034165387
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K082128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: 189155508
• Device Catalogue Number: 189155508
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1