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	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.(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) 2019, a patient had a depuy synthes spine concorde lift spacer collapse and retro pulse into the neuro canal at the l4/l5 level.It is not known why the implant collapsed and retropulsion into the patient¿s spinal canal.It happened at an unknown time after the primary surgery to implant the concorde lift device.The patient was experiencing back and leg pain which led to the primary surgery.The patient underwent posterior spinal fusion to explant the defective device and replace it with additional implants.The lift spacer was removed through an anterior approach and replaced with a synfix evo spacer.The device was discarded.The procedure and patient consequences were unknown.This report is for one (1) concorde lift, convex 9x21.This is report 1 of 1 for pc-(b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image provided.The image was reviewed, and the complaint condition could be confirmed because the implant migration at l4/l5 level can be seen in the provided x-ray image.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• 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: 9437444
• Report Number: 1526439-2019-52642
• Device Sequence Number: 17143624
• Product Code: MAX
• UDI-Device Identifier: 10705034531601
• UDI-Public: (01)10705034531601
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/31/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR