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

Catalog Number	197811023L
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).Device is still implanted.
Event or Problem Description
The following was reported: a concorde lift cage implanted (b)(6) 2018.Part number and lot number unknown).L5-s1 isthmic spondylolisthesis.11x23mm cage achieved 4mm of expansion.In (b)(6) 2019, the cage partially collapsed; the surgeon explained that a large amount of bone was used to fill and back fill the cage during procedure.Ct scan confirmed partial fusion/ bone seen inside and across the implant.Obesity was noted as a clinical factor.
Additional Manufacturer Narrative
Product complaint # = > (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: 8484165
• Report Number: 1526439-2019-51504
• Device Sequence Number: 1922378
• Product Code: MAX
• UDI-Device Identifier: 10705034531564
• UDI-Public: 10705034531564
• Combination Product (Y/N): N
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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 Catalogue Number: 197811023L
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 04/27/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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: Required Intervention