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

Model Number	1978-09-023L
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 surgery due to the concord lift implant collapsing.It was also noted that two (2) screws were broken and thought to be caused by the collapsing cage.This was discovered through a follow-up x-ray with the patient.All four (4) of the previous matrix screws were removed and replaced with four (4) matrix screw 7x45.Procedure outcome and patient status are unknown.Concomitant devices: screws (part: 04.632.645, lot: unknown, quantity: 4), locking caps (part: unknown, lot: unknown, quantity: 4), rod (part: unknown, lot: unknown, quantity: 2).This report is for a concorde lift, lordotic 9x23.This is report 1 of 1 for (b)(4).The broken screws are captured under (b)(4).

• Brand Name: CONCORDE LIFT, LORDOTIC 9X23
• 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: 9795233
• Report Number: 1526439-2020-00656
• Device Sequence Number: 11334884
• Product Code: MAX
• UDI-Device Identifier: 10705034531571
• UDI-Public: (01)10705034531571
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• 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: 1978-09-023L
• Device Catalogue Number: 197809023L
• 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: 03/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention