MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONCORDE LIFT, LORDOTIC 11X23; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	1978-11-023L
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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 on an unknown date, the concorde lift cage was losing its expansion.The surgeon intends to monitor the patient and if nothing change, he does not plan to perform a revision surgery.It was unknown if there was a surgical delay.Procedure outcome and patient status are unknown.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The concorde lift, lordotic 11x23 was not returned to the customer quality unit for evaluation.It was noted that the device remains implanted.However, x-ray image of the device was provided to customer quality unit on may 10, 2019.It can be seen in the images that there has been loss in height of the cage.It is unknown how the concorde lift is losing its expansion.Should more information and/or the device sample become available at a later date, this complaint file will be reopened and the device will then receive a full evaluation.A review of the device history record did identify a nonconformance.It was determined that the nonconformance is not relevant to the reported event.Nonconforming devices were reworked and released accomplishing all quality specifications.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return of the concorde lift, lordotic 11x23 we are unable to identify the root cause.As the device was released meeting all quality requirements, no further complaint action is required.Should more information and/or the device sample become available at a later date, this complaint file will be reopened, and the device will then receive a full evaluation.

• Brand Name: CONCORDE LIFT, LORDOTIC 11X23
• 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: 8617535
• Report Number: 1526439-2019-51646
• Device Sequence Number: 14026786
• Product Code: MAX
• UDI-Device Identifier: 10705034531564
• UDI-Public: (01)10705034531564
• Combination Product (Y/N): N
• 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): 04/24/2019

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: 12/31/2022
• Device Model Number: 1978-11-023L
• Device Catalogue Number: 197811023L
• Device Lot Number: 198423
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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-1226-2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR