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	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint : (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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 there was a concorde lift removal due to collapsed height.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The cage was returned in its collapsed form.Bone tissue is readily visible inside the cage.Tool marks are visible on one side of the cage.The screw head also features material deformation, indicating stresses placed on it during use.These marks appear on all sides of the screw head.Torqueing the screw head inside the cage was difficult.After the tissue inside yielded to the torque slightly, the screw head could not be turned any farther.Disassembling the cage further could disrupt the issue.Regardless, the cage was returned collapsed and could not be reset to its expanded form.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The root cause of the cage collapsing postoperatively cannot be determined from the sample and the information provided.Further dynamic testing will be performed.Relevant actions are being taken to address the issue.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: 8657714
• Report Number: 1526439-2019-51699
• Device Sequence Number: 14025021
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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 Expiration Date: 08/31/2023
• Device Model Number: 1978-09-021C
• Device Catalogue Number: 197809021C
• Device Lot Number: 205830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2019
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/02/2019
• 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: 47 YR