MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT, CONVEX 9X26; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	197809026C
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If 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.(b)(4).
Event or Problem Description
It was reported that the interbody cage retropulsed.Did the patient experience a post-op device malfunction? unknown.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown.Did the patient require revision surgery or hardware removal? unknown.Patient status/ outcome / consequences? unknown.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study? unknown.(b)(4).By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst: true.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).

• Brand Name: CONCORDE LIFT, CONVEX 9X26
• 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: 8484320
• Report Number: 1526439-2019-51506
• Device Sequence Number: 1761479
• Product Code: MAX
• UDI-Device Identifier: 10705034531526
• UDI-Public: 10705034531526
• Combination Product (Y/N): N
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2019

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 Catalogue Number: 197809026C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 05/17/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 04/24/2019; 05/24/2019
• 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