MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT, LORDOTIC 9X23; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1978-09-023L
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
It was reported dr (b)(6) ((b)(6) hospital in (b)(6) sent (b)(6) (sr.Sales consultant, (b)(6) images from a six-month follow-up on (b)(6) 2018 that showed a potential collapse of a lordotic concorde lift implant.The implant in question is at the l4-l5 level of a 2-level tlif l4-s1 that was completed in late (b)(6) 2018.Patient is currently experience axial back pain with no radicular pain.No revision surgery is planned as of now, dr (b)(6) plans to monitor the patient for a few more months and go from there.Attached is an image comparing the 2-week follow-up x-ray on (b)(6) 2018 (left) to the 6-month follow-up x-ray on (b)(6) 2018 (right).

• Brand Name: CONCORDE LIFT, LORDOTIC 9X23
• 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: 8264785
• Report Number: 1526439-2019-51257
• Device Sequence Number: 16538615
• Product Code: MAX
• UDI-Device Identifier: 10705034531571
• UDI-Public: (01)10705034531571
• Combination Product (Y/N): N
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

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 Model Number: 1978-09-023L
• Device Catalogue Number: 197809023L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other