MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE SYSTEM INSERTER, STRAIGHT; DRIVER, PROSTHESIS

Model Number	287901000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 this was a lumbar interbody fusion (l2/3) for the spondylolisthesis (b)(6) 2021.The concorde system inserted could not grasp the concorde cage.The procedure was successfully completed using another cage and was able to grasp it with the inserter without issue.The surgery was completed successfully within 30 minutes delay.The patient outcome was stable.No further information is available.This report is for one (1) concorde system inserter, straight.This is report 1 of 1 for (b)(4).

• Brand Name: CONCORDE SYSTEM INSERTER, STRAIGHT
• Common Device Name: DRIVER, PROSTHESIS
• 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: 12815711
• Report Number: 1526439-2021-02415
• Device Sequence Number: 12140496
• Product Code: HWR
• UDI-Device Identifier: 10705034219882
• UDI-Public: 10705034219882
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: 287901000
• Device Catalogue Number: 287901000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONCORDE PROTI, P, 9X7X23 MM
• Patient Sex: Unknown