MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT, LORDOTIC 11X23; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1978-11-023L
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that a lumbar fusion was performed and a concorde lift interbody was placed in the disc space.A recent ct scan, for an unrelated issue) showed the cage had collapsed in comparison to the post operative ct that was administered.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: CONCORDE LIFT, LORDOTIC 11X23
• 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: 8619639
• Report Number: 1526439-2019-51648
• Device Sequence Number: 2172982
• Product Code: MAX
• UDI-Device Identifier: 10705034531564
• UDI-Public: (01)10705034531564
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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 Model Number: 1978-11-023L
• Device Catalogue Number: 197811023L
• Device Lot Number: 198423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1226-2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other