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 Code Available (3191)
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 on an unknown date, after spinal fusion procedure patient has probable partial collapse of concorde lift implant.Surgeon noticed at follow up appointment on (b)(6) 2019 that the patient has new slight back pain and looked fused, but no new leg pain which he had before surgery.Surgeon plans to continue follow up and reevaluate at next visit.Procedure outcome and patient consequence are unknown.This complaint involves one (1) device.
Additional Manufacturer Narrative
(b)(4).

• 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: 8698038
• Report Number: 1526439-2019-51752
• Device Sequence Number: 2247561
• Product Code: MAX
• UDI-Device Identifier: 10705034531571
• UDI-Public: (01)10705034531571
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 1978-09-023L
• Device Catalogue Number: 197809023L
• Device Lot Number: 204548
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/19/2019
• 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
• Patient Age: 58 YR