MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT, CONVEX 11X21; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	197811021C
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The device is still implanted in patient.
Event or Problem Description
It was reported that dr (b)(6) sent me an image of a patient at one month post op, and three months post op.The concorde lift cage height appears to have changed from one month to three months.Did the patient experience a post-op device malfunction? yes, if yes, please describe.The concorde lift cage height appears to have changed from one month to three months.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? no, did the patient require revision surgery or hardware removal? no, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? none, patient status/ outcome/consequences? no, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study? unknown, ip-00528400: device property of? none, device in possession of? patient.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).Udi: ((b)(4).The concorde lift cage was not returned to the complaint handling unit.The returned images show that the sample is still implanted.Additional information provided states that revision surgery was not required.The sample is not expected to be returned at this time.The returned x-rays show the cage in two different positions/alignments.A review of the device history record could not be performed as the lot number is unknown.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The returned images are sufficient to determine that the position and alignment of the cage have changed.However, without the cage itself, we are unable to identify a potential root cause.As no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.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 11X21
• 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: 8484141
• Report Number: 1526439-2019-51503
• Device Sequence Number: 19200285
• Product Code: MAX
• UDI-Device Identifier: 10705034531540
• UDI-Public: 10705034531540
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171425
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 197811021C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/17/2019
• 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