MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE BUL LOR 9X10X23, 5 DG; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	187823410
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The concorde bullet 5 degree lordotic cage was not returned to the customer quality unit for evaluation.A review of the device history record (dhr) for the concorde bullet 5 degree lordotic cage could not be performed as no lot number was provided.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting per work instruction.Without the return of the concorde bullet cage we are unable to confirm the reported issue or identify the root cause.As the device was not returned for evaluation we are unable to confirm the reported issue.As such, no further complaint action is required.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 the surgeon was trying to place a cage at l5-s1 disc space.He was coming in laterally then pulled his hand down with inserter to drive the cage to a more midline approach and the cage broke off at the instrument/cage interface.This happened with both cages.Then proceeded to use the dual prep instrument to get more midline and then the third cage was placed to his satisfaction.

• Brand Name: CONCORDE BUL LOR 9X10X23, 5 DG
• 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: 7411969
• Report Number: 1526439-2018-50332
• Device Sequence Number: 1264130
• Product Code: MAX
• UDI-Device Identifier: 10705034139517
• UDI-Public: (01)10705034139517
• Combination Product (Y/N): N
• Initial Reporter State: KY
• PMA/510(K) Number: K041722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2018

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: 187823410
• Device Catalogue Number: 187823410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1