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

Model Number	1978-09-021C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).Device was used for treatment, not diagnosis.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 on (b)(6) 2020, the surgeon performed a revision of concorde lift cage and a broken cortical fix screw.The surgeon replaced the cage and left the remaining screw shank in the patient after confirming it was fully buried in the body of l3.They believe the cage lost some height and failed to fuse.No further information provided.Concomitant devices reported: 5.5 ti cort fix 6x50mm (part#: 186731650, lot#: 218438, quantity#: 1).This is report 1 of 2 for (b)(4).

• Brand Name: CONCORDE LIFT, CONVEX 9X21
• Common Device Name: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9805850
• Report Number: 1526439-2020-00665
• Device Sequence Number: 19583845
• Product Code: MAX
• UDI-Device Identifier: 10705034531601
• UDI-Public: (01)10705034531601
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2020

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
• Device Lot Number: 203128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention