MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH COUGAR LS 18X8X60 LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	189160508
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Weakness (2145); Foreign Body In Patient (2687); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 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.
Event or Problem Description
It was reported that on an unknown date, patient had l4-5 direct lateral interbody fusion 7 days prior.The patient began having leg/hip flexor weakness and came to the emergency room.It was determined that the cage had migrated.There were unknown patient consequences.The patient require revision surgery on (b)(6) 2019 due to cage migration.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).The device features signs of use such as surface marking.However, the device featured no signs of migrating or backing out.No other damage was noted.No postoperative x-ray images were provided.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The root cause of the device migrating/backing out postoperatively cannot be determined from the sample and information provided.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: COUGAR LS 18X8X60 LORDOTIC
• 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: 8798051
• Report Number: 1526439-2019-51837
• Device Sequence Number: 2484783
• Product Code: MAX
• UDI-Device Identifier: 10705034166162
• UDI-Public: (01)10705034166162
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082128
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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 Model Number: 189160508
• Device Catalogue Number: 189160508
• Device Lot Number: 508917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention