MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CAGE/SPACER: COUGAR; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

Device Problems Break (1069); Migration (4003)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients treated with depuy synthes oracle lateral interbody cages and cougar ls lateral cage system during fusion procedures in the lumbar spine between january 1, 2008, and april 30, 2022.A total of 161 patients (65 males and 96 females, mean age of 58 years) in the oracle group and 375 patients (159 males and 216 females, mean age of 61 years) in the cougar group were included in the study.The complications as per icd 9 & 10 categorization identified in premier healthcare database were reported as follows: oracle lateral interbody cages: 1 patient had reoperation within 0-3 months after index procedure due to infection.4 patients had revision within 0-3 months after index procedure.11 patients had revision within 0-12 months after index procedure.8 patients had revision within 13-24 months after index procedure.Among the total of 19 patients who had revision, 2 patients had back pain and 12 patients had device-related complications such as mechanical complications, breakdown and displacement of the fixation device.Cougar ls lateral cage system: 3 patients had reoperation within 0-3 months after index procedure of which 1 was due to infection and 2 due to dural tear.12 patients had revision within 0-3 months after index procedure.18 patients had revision within 0-12 months after index procedure.5 patients had revision within 13-24 months after index procedure.Among the total of 23 patients who had revision, 7 patients had radiculopathy, 2 patients had pseudarthrosis and 8 patients had device-related complications such as mechanical complications, breakdown and displacement of the fixation device.This is for depuy spine cougar lateral cages system.A copy of the clinical evaluation form is being submitted with this regulatory report.This report involves one unk - cage/spacer: cougar.This is report 4 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown cage/spacer: cougar/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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.

• Brand Name: UNK - CAGE/SPACER: COUGAR
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17682154
• MDR Text Key: 322616832
• Report Number: 1526439-2023-01586
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention