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 Code	No Code Available (3191)
Date of Event	10/24/2018
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
Collapsed height of concorde lift cage.If other, describe --> tlif, did the patient experience a post-op device malfunction? --> no, did the patient experience an adverse event such as infection, non-union, allergic.Reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> unknown, did the patient require revision surgery or hardware removal? --> no, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> no, (b)(4).Device property of -->patient, device in possession of -->implanted.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.This complaint involves 1 product.

• 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: 8842392
• Report Number: 1526439-2019-51897
• Device Sequence Number: 11153399
• Product Code: MAX
• UDI-Device Identifier: 10705034531601
• UDI-Public: (01)10705034531601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/08/2019

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: 1978-09-021C
• Device Catalogue Number: 197809021C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/30/2019
• 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-1225-2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 74