MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT, CONVEX 9X21; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1978-09-021C
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
The following was reported: surgery went as planned, no issues.Surgeon texted photos showing implant had collapsed.Do not have additional information at this time.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Udi: ((b)(4).Recall res event#: 82587-cts recall rcl190236 a product investigation was completed: the concorde lift convex 9x21mm cage was returned to the complaint handling unit after the initial closure of the complaint.While the x-ray images showed that the cage had collapsed, this could not be directly replicated in testing.The cage could be opened and closed as intended.The dimensions of the cage's basic features were investigated and were all within specifications.A review of the device history record (dhr) was performed on the concorde lift convex 9x21mm cage.No discrepancies were observed during the manufacturing process.As a result, a review of the dhr identified no issues during the manufacturing and release of this cage.This cage was released from manufacturing meeting all quality requirements.The root cause of the cage collapsing postoperatively cannot be determined from the sample and the information provided.A potential root cause cannot be determined from the sample and information.The returned sample and images returned were enough to show that the cage had collapsed postoperatively.Further dynamic testing will be performed.Relevant actions are being taken to address the issue.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Pc: surgical intervention in the form of revision surgery device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: CONCORDE LIFT, CONVEX 9X21
• 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: 8186193
• Report Number: 1526439-2018-51172
• Device Sequence Number: 1326977
• Product Code: MAX
• UDI-Device Identifier: 10705034531601
• UDI-Public: (01)10705034531601
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 1978-09-021C
• Device Catalogue Number: 197809021C
• Device Lot Number: 197020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 02/12/2019; 02/26/2019; 04/18/2019
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/12/2019; 03/14/2019; 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention